My Search for a Psychiatric Bed in an Overburdened Health System By Helen Santoro Illustration by Oona Zenda July 9, 2026

https://kffhealthnews.org/health-industry/psychiatric-bed-shortage-overburdened-health-system/?utm_campaign=KHN%3A%20Colorado&utm_medium=email&_hsenc=p2ANqtz-8TY--1dxjW4tJ05YujqtJaBJGj61leCkxCZbvrAw25gk44NCSQduCs6aotWi9mmI1q359L-u1zDpAcKaA5SD1k4XixJQ&_hsmi=430352733&utm_content=430352733&utm_source=hs_email By Helen Santoro Eight days before my 33rd birthday in April, a social worker at a crisis clinic near Denver determined I was an imminent danger to myself. She placed me on an involuntary 72-hour mental health hold. What came next wasn’t treatment, but a search for a bed. Clinic staffers called area hospitals with inpatient psychiatric units, asking if they had available beds. They didn’t. So, I was told I had to spend the night at the clinic, which is open 24/7. I settled into a recliner, trying to make myself comfortable as my mind drifted in a blank, disassociated haze. Sleep came in brief bursts. Since the 1950s, the United States has seen a dramatic decline in the number of psychiatric beds nationwide due in part to deinstitutionalization and the rise of antipsychotics. But that has created a critical shortage for those needing help. From 2011 to 2023, the number of hospitals with inpatient psychiatric units dropped significantly, according to a 2025 study. Another study from that year found that this country has 28.4 inpatient psychiatric beds per 100,000 people — not even half the 60-bed ratio researchers frequently refer to as the optimal level. The shortage has created what the American Psychiatric Association calls a crisis: emergency rooms overwhelmed with people suffering from severe mental health illnesses, inpatient stays prematurely shortened to speed up bed turnover, and acutely ill individuals left without critical care.

How Many Uninsured Are in the Coverage Gap and How Many Could be Eligible if All States Adopted the Medicaid Expansion? Authors: Sammy Cervantes, Clea Bell, Jennifer Tolbert, and Anthony Damico Published: Jul 27, 2026

https://www.kff.org/medicaid/how-many-uninsured-are-in-the-coverage-gap-and-how-many-could-be-eligible-if-all-states-adopted-the-medicaid-expansion/ This analysis estimates that 1.2 million uninsured individuals in the ten states without Medicaid expansion, including many working adults, people of color, and those with disabilities, remain in the "coverage gap," ineligible for Medicaid or for tax credits that would make coverage affordable through the Affordable Care Act's Marketplaces.

Donor Government Funding for HIV Drops by $2.1 Billion in 2025 Due to Declines in Funding from the United States, Marking Largest Annual Decrease Since Scale-up for the HIV Response Began Published: Jul 27, 2026

https://www.kff.org/global-health-policy/donor-government-funding-for-hiv-drops-by-2-1-billion-in-2025-due-to-declines-in-funding-from-the-united-states-marking-largest-annual-decrease-since-scale-up-for-the-hiv-response-began/ Donor government funding to combat HIV in low- and middle-income countries fell by $2.1 billion in 2025, a 25% decrease from the previous year, according to a new report by KFF and the Joint United Nations Programme on HIV/AIDS (UNAIDS). Total disbursements dropped to $6.2 billion in 2025, down from $8.3 billion in 2024, marking the largest single-year decline since donor funding scale-u

Donor Government Funding for HIV in Low- and Middle-Income Countries in 2025 Authors: Adam Wexler, Jennifer Kates, and Stephanie Oum Published: Jul 27, 2026

https://www.kff.org/global-health-policy/donor-government-funding-for-hiv-in-low-and-middle-income-countries-in-2025/ This report provides an analysis of donor government funding to address the HIV response in low- and middle-income countries in 2025, the latest year available, as well as trends over time. It includes both bilateral funding from donors and their multilateral contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), UNITAID, and Joint United Nations Programme on HIV/AIDS (UNAIDS).

KFF Health Tracking Poll: Ebola & Pandemic Preparedness Authors: Lunna Lopes, Isabelle Valdes, Audrey Kearney, Mardet Mulugeta, and Liz Hamel Published: Jul 28, 2026

https://www.kff.org/public-opinion/kff-health-tracking-poll-ebola-pandemic-preparedness/ Much of the public has yet to form an opinion on the U.S. government’s response to the Ebola outbreak in the Democratic Republic of the Congo, this poll finds. Four in ten adults say the U.S. is less prepared for a pandemic now than it was in 2020.

Comparing U.S. Ebola Outbreak Response Capabilities and Practices Over Time Authors: Josh Michaud and Jennifer Kates Published: Jul 28, 2026

https://www.kff.org/global-health-policy/comparing-u-s-ebola-outbreak-response-capabilities-and-practices-over-time/ This brief compares the U.S. response to the current Ebola outbreak in DRC with U.S. responses to prior Ebola outbreaks across a variety of characteristics. It finds the US is on par or even faster with response funding, but the restructuring of the US response mechanisms and leadership (such as eliminating USAID) since 2025 have changed the organizational approach with unknown consequences, and how the US is engaging with international partners is different now.

How Has ACA Marketplace Enrollment Changed Across States in 2026? Authors: Justin Lo, Matt McGough, and Cynthia Cox Published: Jul 28, 2026

https://www.kff.org/affordable-care-act/how-has-aca-marketplace-enrollment-changed-across-states-in-2026/ Following several years of rapid enrollment growth in the Affordable Care Act (ACA) Marketplaces that corresponded with temporary enhanced premium tax credits, enrollment fell for the first time in seven years in 2026, when those tax credits expired. Every state except for New Mexico saw a drop in ACA Marketplace enrollment from 2025 to 2026. State-based Marketplaces that run their own enrollment platforms, including those that partially offset the expiring federal enhanced tax credits, generally…

Most Aren’t Confident in the CDC and FDA to Make Recommendations About Childhood Vaccine Schedules Published: July 28, 2026

https://www.kff.org/quick-insights/most-arent-confident-in-the-cdc-and-fda-to-make-recommendations-about-childhood-vaccine-schedules/ Most adults (56%) say they have “little” to “no confidence” in federal health agencies like the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to make recommendations about childhood vaccine schedules.

Are Health Care Costs THE Top Issue for Voters? Author: Drew Altman Published: Jul 29, 2026

https://www.kff.org/from-drew-altman/are-health-care-costs-the-top-issue-for-voters/ In a new column, Dr. Drew Altman, Founding President and CEO, analyzes the polling on health costs as a voting issue and concludes that there is no one top voting issue. He writes: “I have come to the conclusion that the search for a single top issue through polling questions—whether it’s health costs, or gas prices, or the cost of food—is artificial. People worry about and experience these costs together. There is no top issue,…

What Could Medicaid Work Requirements Mean for SSI Applicants? Authors: Abby Sachar, Amaya Diana, Alice Burns, and Jennifer Tolbert Published: Jul 29, 2026

https://www.kff.org/medicaid/what-could-medicaid-work-requirements-mean-for-ssi-applicants/ Medicaid work requirements may make it more difficult for some SSI applicants to maintain coverage due to the added complexity of navigating the verification process for the medical frailty exclusion. KFF's policy analysis explains why SSI applicants are particularly at risk of going uninsured under the new Medicaid rules.

CMS’s Decision to End Temporary Subsidies to Medicare’s Stand-Alone Drug Plans Could Mean Larger Premium Increases for Some Beneficiaries Next Year Juliette Cubanski Juliette Cubanski

https://www.kff.org/quick-insights/cmss-decision-to-end-temporary-subsidies-to-medicares-stand-alone-drug-plans-could-mean-larger-premium-increases-for-some-beneficiaries-next-year/ Without these extra subsidies in place for 2027, some Part D stand-alone drug plan (PDP) enrollees could see a larger premium increase for drug coverage next year than they’ve faced in recent years, though plan-specific premium amounts are not yet known. While some policymakers questioned the rationale for and cost of the premium stabilization demonstration, which totaled $9.8 billion in 2025 and 2026, the extra subsidies worked as intended to stabilize year-over-year PDP premium increases…

Medicare’s Proposed Cut to 340B Drug Payments Would Hit Safety-Net Hospitals While Benefiting For-Profit Hospitals Authors: Scott Hulver, Zachary Levinson, Juliette Cubanski, and Meredith Freed Published: Jul 29, 2026

https://www.kff.org/health-costs/medicares-proposed-cut-to-340b-drug-payments-would-hit-safety-net-hospitals-while-benefiting-for-profit-hospitals/ This analysis finds that CMS’s proposed cut to Medicare reimbursement for 340B drugs, and accompanying increase for other outpatient services, would reduce revenues among safety-net hospitals while increasing revenues among for-profit hospitals.

Donor Government Funding for HIV Dropped by $2.1 Billion in 2025 Due to Declines in U.S. Disbursements, Marking the Largest Annual Decrease Since HIV Response Scale Up Began Published: July 29, 2026

https://www.kff.org/quick-insights/donor-government-funding-for-hiv-drops-by-2-1-billion-in-2025-due-to-declines-in-u-s-disbursements-marking-largest-annual-decrease-since-hiv-response-scale-up-began/ Donor government funding to combat HIV in low- and middle-income countries fell by $2.1 billion in 2025, a 25% decrease from the previous year. The 2025 decrease was driven by a decline in U.S. disbursements following the administration’s substantial cuts in global health funding, programs, and personnel. Despite this decline, the U.S. remains the largest donor to HIV in the world.

KFF Health Tracking Poll: Mifepristone and the Midterms Authors: Isabelle Valdes, Audrey Kearney, Lunna Lopes, Mardet Mulugeta, and Liz Hamel Published: Jul 30, 2026

https://www.kff.org/public-opinion/kff-health-tracking-poll-mifepristone-and-the-midterms/ Amid an ongoing FDA re-review of mifepristone, awareness of the safety and prevalence of the abortion pill remains limited. This KFF poll also finds that the voters who say abortion policy is an important issue for 2026 midterm candidates to discuss are disproportionately Democrats.

Health and Health Care Experiences of Uninsured Immigrants Authors: Drishti Pillai and Samantha Artiga Published: Jul 30, 2026

https://www.kff.org/immigrant-health/health-and-health-care-experiences-of-uninsured-immigrants/ This brief provides data on health and health care experiences of uninsured immigrant adults based on a KFF survey of immigrant adults ages 18 and older conducted in partnership with The New York Times in Fall 2025. The data provide insight into how the projected coverage losses under the 2025 reconciliation law may impact health and health care for immigrant families as more lawfully present immigrants become uninsured.

Five Key Facts About People Experiencing Homelessness Authors: Akash Pillai and Heather Saunders Published: Jul 31, 2026

https://www.kff.org/medicaid/five-key-facts-about-people-experiencing-homelessness/ This data note reviews trends in homelessness and characteristics of people who are homeless using data from HUD’s Point-in-Time (PIT) count of sheltered and unsheltered people experiencing homelessness.

Are Health Care Costs THE Top Issue for Voters? Author: Drew Altman Published: Jul 29, 2026

https://www.kff.org/from-drew-altman/are-health-care-costs-the-top-issue-for-voters/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-9GpF4kaEQFREQus_5gNzfPHLOBxilDZtjjJGJ_z_RlnxZH3TAy3I8-j71acem-NzDD4Z9mrtjkG3E0WzVbg0gA4ScTBw&_hsmi=431040760&utm_content=431040760&utm_source=hs_email In a new column, Dr. Drew Altman, Founding President and CEO, analyzes the polling on health costs as a voting issue and concludes that there is no one top voting issue. He writes: “I have come to the conclusion that the search for a single top issue through polling questions—whether it’s health costs, or gas prices, or the cost of food—is artificial. People worry about and experience these costs together. There is no top issue, unless that issue is the catchall, ‘cost of living.’”

Syphilis spreads while researchers contend with federal constraints and a drug shortage End to cross-border collaboration makes infections easier to miss By Eric BoodmanJuly 31, 2026

https://www.statnews.com/2026/07/31/syphilis-drug-shortage-case-study-san-diego-patient-researcher-advocate/

Governing the Attention Dividend: AI-Reclaimed Clinician Capacity as a Health Policy Resource Yusuke Shono, MD, PhD, Vice Director

https://academic.oup.com/healthaffairsscholar/advance-article/doi/10.1093/haschl/qxag197/8748697?rss=1&login=false

Corporate Consolidation And The Youth Mental Health Crisis: Evidence From Medicaid Managed Care In 2022 Authors: K. John McConnell mcconnjo@ohsu.edu, Sara Edelstein, Courtney Benjamin Wolk, Kelsey Watson, Katherine Courchaine, Stephan Lindner, and Jane M. Zhu

https://www.healthaffairs.org/doi/10.1377/hlthaff.2025.01619 Medicaid managed care organizations serve as the primary vehicle for delivering behavioral health services to low-income youth. However, market consolidation has shifted enrollment toward a handful of large national parent firms. Understanding the implications of this shift is critical for identifying and closing gaps in adolescent mental health services. Using national Medicaid claims data from 2022, we examined the associations between managed care organization ownership by five major parent firms and measures of youth mental health service use and provider composition. Managed care organizations owned by large national parent firms were characterized by lower mental health screening rates and, for most firms, higher use of emergency department, inpatient, and medication-based care, including psychotropic prescribing without psychotherapy. Provider composition also varied by firm, suggesting differences in how these organizations structure their behavioral health networks, with some relying more heavily on psychiatrists and psychologists and others depending more on master’s-level therapists. The growing influence of large national parent firms in shaping behavioral health access for Medicaid-enrolled youth underscores the need for closer scrutiny of how managed care structures serve youth with significant mental health needs.

The Accumulated Inconvenience Of Insurance Coverage Denials Margaret Winchester July 31, 2026

https://www.healthaffairs.org/content/forefront/accumulated-inconvenience-insurance-coverage-denials?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz-_YlaBOABIAjFjEZ0HKiSgfaSOmyl_Yq8v2vvnZdV2099z_Hw116oUoQmWwX0o2WLEEeTbeG8CnwWn3aMEddcB5dOVLvg&_hsmi=431087348&utm_source=hasu In a new book review, Senior Editor Margaret Winchester reviews Coverage Denied: How Health Insurers Drive Inequality in the United States by Miranda Yaver.

Reducing Barriers To Out-Of-State Pediatric Care Through The Accelerating Kids’ Access To Care Act Joshua GreenbergandNick Manetto July 27, 2026

https://www.healthaffairs.org/content/forefront/reducing-barriers-out-state-pediatric-care-through-accelerating-kids-access-care-act?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz--GbnzX_-1_MArWSRCC8j2T9n0ejEyt8rx1dzzinkVU8XuxatiGRwvdl-sMxSpGH3jfjZvSxyqba7DILGgOwGB07dW4ow&_hsmi=431087348&utm_source=hasu Pediatrics is increasingly moving toward regionalized hub-and-spoke models organized around comprehensive “centers of excellence.” This shift makes out-of-state care for patients with medically complex conditions more common.

The Trillion-Dollar Algorithm: Lessons From Machine Learning For MA Risk Adjustment Micah Johnson,Divya Shanmugam,David J. Meyers,Jenna Wiens,andEmma Pierson July 28, 2026

https://www.healthaffairs.org/content/forefront/trillion-dollar-algorithm-lessons-machine-learning-ma-risk-adjustment?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz--gCoo-sWBMP5fSFkw_NJMMmh9sDoxaFzGQrIOWf3HL_N5Xn9wzwJpRV34TpUYtp_kX7VztfJiVTXaaceeGccqDIAd0gA&_hsmi=431087348&utm_source=hasu The current MA risk adjustment model has shortcomings, both in predictive accuracy and payment equity across the Medicare program, which could be mitigated using lessons from machine learning.

One Shot Or Three? Understanding The Measles-Mumps-Rubella (MMR) Vaccine T. Joseph Mattingly II July 27, 2026

https://www.healthaffairs.org/content/forefront/one-shot-three-understanding-measles-mumps-rubella-mmr-vaccine?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz-8RZpRj1WQPAtTqL67oIri8_tUDywvYeDV1tUgJR-x3QAaICYXBpKDfNb9HXhK8gnZoPYMk9rdihUUm1boMC1dItjM8Ow&_hsmi=431087348&utm_source=hasu Since 1971, protection against measles, mumps, and rubella has been delivered in a single combined injection. A proposal to separate the vaccine into three separate shots could compound the coverage declines now allowing measles to reemerge.

The Equity Cliff: Federal Medicaid Cuts Are About To Undo California’s Health System Gains Jim Hickman,Abner Mason,andJeremy Cantor July 29, 2026

https://www.healthaffairs.org/content/forefront/equity-cliff-federal-medicaid-cuts-undo-california-s-health-system-gains?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz--KYlRxKG3FUFmLMf2k0fvOrdQ0E4Wllu1Nlv3zk2dbcAJigozQx7zavXccLxTC9neJJEPe7bf_gLzk9GJf4eqJc_j-_A&_hsmi=431087348&utm_source=hasu What California chooses in the next six months will determine whether a decade of Medicaid transformation holds or collapses and how the health and well-being of thousands or millions of California’s most vulnerable people will change as a result.

A Technological Agenda For Risk-Adjustment Reform Daniel K. Shenfeld,Ravi Parikh,andEzekiel J. Emanuel July 28, 2026

https://www.healthaffairs.org/content/forefront/technological-agenda-risk-adjustment-reform?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz-9S0jnBUbUfI2hLtgfkqRCzSwV3hw4I6opDa84JjmAa0xh55WjRUdCPvgpUBtWGfUyoyA6FMcuK18m5UN_gwUJD0Cl5tw&_hsmi=431087348&utm_source=hasu Instead of sporadically updating antiquated models, CMS must develop a new risk-adjustment platform. This will require the technology and analytics infrastructure to evaluate, deploy, and update models annually—or even faster.

Assessing The Value Of Post-Approval Research For U.S. Policy Makers Dan CrippenandKirsten Axelsen July 29, 2026

https://www.healthaffairs.org/content/forefront/research-agenda-assess-value-post-approval-drug-research-us-policy-makers?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz-_FCqOr2kF_ta9ahMTd5ILrFUwTVgNYGbls_jGE-t9r2PNwR3SdlRTBmr64ju01JDSnfS20doofvh_PJsJDsiZK8e4aVA&_hsmi=431087348&utm_source=hasu Understanding the impact of price controls on drug research and approvals of secondary indications is critical for policy makers considering the expansion of price setting within and beyond the Inflation Reduction Act.

The Trump Administration’s Deals With Pharma: Policy Progress Or Political Theater? Matthew Vogel,Sanam Rangaraj,andOlivier J. Wouters July 30, 2026

https://www.healthaffairs.org/content/forefront/trump-administration-s-deals-pharma-policy-progress-political-theater?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz--JEZa6N-YbHuWPJsWzocybjgDIbLV-QadZtSGMMBZgxB6my6PLPmk-_8TIWzDbYxu_rVZhEIR-He-bwAjd8d_v3asBGQ&_hsmi=431087348&utm_source=hasu Many details of these agreements remain undisclosed, but what we know suggests they may be less far-reaching than claimed.

The Collision Of 340B Pricing And Medicare Drug Price Negotiation Rory MartinandKatheryne Richardson July 31, 2026

https://www.healthaffairs.org/content/forefront/collision-340b-pricing-and-medicare-drug-price-negotiation?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz-8oXXeko6f_Dr2Ne_7MDNL6ehMj9cMJDDnENSy6Rj9q7PO8pAsz-hZVU29t2gYeY_4Xwfr3npOzTIXEJT5Iy_8W9yFF1Q&_hsmi=431087348&utm_source=hasu When the first set of prices under the Medicare Drug Price Negotiation Program went into effect, they intersected with the 340B Drug Pricing Program and created the potential for billions of dollars in duplicate discounts and administrative complexity.

When the Payer Defines the Product: How a Medicare Pricing Rule Would Deepen the Divide in Cancer Care Gary A. Puckrein, PhD | President and Chief Executive Officer of the National Minority Quality Forum July 26, 2026

https://www.healthaffairs.org/sponsored-content/national-minority-quality-forum/when-the-payer-defines-the-product?utm_campaign=34032557-Health%20Affairs%20Sunday%20Update%202026&utm_medium=email&_hsenc=p2ANqtz-96B7IKIODIgyxkBOlk1uzQ8I8LZvtoOd-Wns55uYuzpjHiM162s2GqfkYavHA1hDC-su94HoKNz3GJHsgICLYYoWxTdA&_hsmi=431087348&utm_content=431087348&utm_source=hs_email Publisher's note: This material was paid for by National Minority Quality Forum and provided by National Minority Quality Forum. The views expressed by the author are their own. This material is not part of Health Affairs Forefront; it has not been subject to editorial review or revision by Health Affairs or Health Affairs Forefront except to avoid offensive, dangerous, or deceptive content and to conform with Health Affairs style conventions.

Health Care Price Transparency: Policy, Practice, and Impact Christopher M. WhaleyandLaura Tollen August 19, 2026, 1:00 PM

https://www.healthaffairs.org/do/10.1377/he20260715.671369/full/?utm_campaign=insidermarketing&utm_medium=email&_hsenc=p2ANqtz--7CCJmuTnWsuZi9tH-JcS00V2xtgQc3SSBp7yiLFnddURuupgaRvg6mEq1VA44NsmbTIzVHSC_2hyWyoAGVqFyhJ9Ueg&_hsmi=431087348&utm_content=eventspecific&utm_source=hasu Both the Trump and Biden administrations embraced and enacted price transparency policies in the health care space, including the Hospital Price Transparency Rule, Transparency in Coverage Rule, and the No Surprises Act, to name a few. But have these policies resulted in better consumer understanding of the prices of their health care services? And how well have plans and hospitals complied with these policies? On August 19, Christopher Whaley of Brown University will join Health Affairs Publishing’s Laura Tollen to get Insiders up to speed on price transparency policies and what to watch moving forward.

Number of Measles Cases Roars Past Last Year's Total As Vaccine Hesitancy Takes Hold

Number of Measles Cases Roars Past Last Year's Total As Vaccine Hesitancy Takes Hold A little more than halfway through the year, the United States has already confirmed more cases — 2,318 — than it had in 2025. Public health experts say a full-throated vaccination push at the national level would stem the tide in cases but acknowledge that seems unlikely under the current administration. Plus, the latest on rising cyclosporiasis cases. https://kffhealthnews.org/morning-briefing/monday-july-27-2026/

Cyclospora Outbreak Prompts Inquiry Into Lettuce Supplier's Ties To White House

Cyclospora Outbreak Prompts Inquiry Into Lettuce Supplier's Ties To White House Rep. Robert Garcia (D-Calif.) has requested documents from Taylor Farms, the White House, the FDA, and the CDC that could shed light on reports that company executives and government officials sought "to distance the company from the outbreak and cast doubt on the officials’ conclusion," The Hill reported. https://kffhealthnews.org/morning-briefing/tuesday-july-28-2026/

Millions On Medicare May Soon See Higher Drug Costs As Trump Ends Subsidy Program

Millions On Medicare May Soon See Higher Drug Costs As Trump Ends Subsidy Program CMS Administrator Dr. Mehmet Oz said Tuesday in a post on social media that the subsidies had been ended because the insurers no longer needed them, The New York Times reported. https://kffhealthnews.org/morning-briefing/wednesday-july-29-2026/

Fauci Invokes Fifth Amendment During Covid Senate Committee Hearing

Fauci Invokes Fifth Amendment During Covid Senate Committee Hearing During a heated Senate hearing Wednesday, Dr. Anthony Fauci invoked his constitutional right not to incriminate himself, reported The New York Times. Republicans, led by Sen. Rand Paul, accused him of causing the coronavirus pandemic, making him personally responsible for every covid death and adverse vaccine reaction. The Senate will decide next week whether to hold Dr. Fauci in contempt. https://kffhealthnews.org/morning-briefing/thursday-july-30-2026/

Viewpoints: To Better Protect Our Kids, We Need Solid Guidance When Wildfire Smoke Streams In; How Are Cities With Clean Needle Programs Faring?

https://kffhealthnews.org/morning-breakout/viewpoints-wildfire-smoke-will-be-back-we-need-a-better-plan-how-are-cities-that-implemented-clean-needle-programs-faring/

Longer Looks: Interesting Reads You Might Have Missed

Longer Looks: Interesting Reads You Might Have Missed Each week, KFF Health News finds longer stories for you to enjoy. Today's selections are on mental health, daylight saving time, "SuperAgers," oral health, and more. https://kffhealthnews.org/morning-breakout/longer-looks-interesting-reads-you-might-have-missed-268/

Most American Kids Are Consuming Caffeine, CDC Study Finds

Most American Kids Are Consuming Caffeine, CDC Study Finds Nearly two-thirds of children ages 2-19 have an average of 19.4 milligrams of caffeine in their diet, according to a CDC report. Soda and baked goodies are two of the big culprits. The American Academy of Pediatrics recommends that children consume no caffeine. https://kffhealthnews.org/morning-breakout/public-health-073126/

Health Insurers Predict A Better Year Ahead In 2027 Amid Medicaid Changes

Health Insurers Predict A Better Year Ahead In 2027 Amid Medicaid Changes Medicaid managed care organizations are trying to reassure investors that Medicaid margins will rise in 2027, marking a trend reversal. But, as Modern Healthcare explained, investors remain skeptical due to looming policy changes and persistently high costs. https://kffhealthnews.org/morning-breakout/health-industry-073126/

Full Senate To Vote Next On CDC Director, Pandemic Preparedness Nominees

Full Senate To Vote Next On CDC Director, Pandemic Preparedness Nominees Despite some shifting reservations, the Senate health committee voted Thursday to advance the nominations of Erica Schwartz as CDC director and Sean Kaufman as assistant secretary for preparedness and response, Stat reported. https://kffhealthnews.org/morning-breakout/administration-news-073126/

Main Cyclosporiasis Outbreak Is Winding Down, But Others Are Emerging

Main Cyclosporiasis Outbreak Is Winding Down, But Others Are Emerging Health officials are trying to identify the sources of five other outbreaks caused by cyclospora — a parasite that causes diarrhea, among other symptoms — as the peak season for this foodborne illness continues, The Hill reported. Other outbreak news is on measles, chronic wasting disease, and Ebola. https://kffhealthnews.org/morning-breakout/outbreaks-and-health-threats-073126/

Connecticut Refugees Struggle To Afford Food After SNAP Benefits Were Cut

Connecticut Refugees Struggle To Afford Food After SNAP Benefits Were Cut According to officials at the state Department of Social Services, SNAP enrollments in Connecticut have dropped by about 35,000 since December, tied in part to new federal work requirements. The CT Mirror reported on the stark reversal in resettlement policies demonstrated by the new federal policy affecting refugee food assistance, as an estimated 1,745 refugees and asylum seekers are expected to lose food aid in Connecticut. https://kffhealthnews.org/morning-breakout/state-watch-073126/

Judge Denies Injunction Against New Medicaid Work Requirements For Sick Patients

Judge Denies Injunction Against New Medicaid Work Requirements For Sick Patients A federal judge denied without prejudice a request filed by Democratic state officials to stop the Trump administration's requirement that chronically ill Medicaid patients prove that they are physically unable to work in order to keep their coverage. https://kffhealthnews.org/morning-breakout/coverage-and-access-073126/

Trump Has Quietly Throttled an Agency Devoted to the Safety of American Healthcare By Arthur Allen July 29, 2026

https://kffhealthnews.org/news/ahrq-funding-grants-trump-healthcare-safety-research-agency-hobbled/ The Trump administration has effectively shut down most of the Agency for Healthcare Research and Quality’s activities, closing the spigot on federal funding estimated to have saved thousands of lives and billions of dollars over the past 27 years by improving medical practice.

Hospice’s Bad Reputation Amid Fraud Crisis Will Hurt Patients, Industry Experts Warn By Laurie Udesky July 29, 2026

https://kffhealthnews.org/aging/hospice-agencies-california-survival-gains-hospital-cms-fraud/ Mark Vantrease regularly sees his Vietnam War buddies over breakfast, attends his grandchildren’s Little League games, and, when he’s up to it, tends to his lush front-yard garden, which is dotted with shells retrieved from his abalone-diving days.

The Politics of Grant Cuts Episode 457 • July 30, 2026 •

https://kffhealthnews.org/podcast/what-the-health-457-trump-grant-cuts-fauci-hearing-covid-july-30-2026/

Abortion Drug Law in Louisiana Heightens Hemorrhage Risk for Pregnant Patients By Halle Parker, Verite News July 30, 2026

https://kffhealthnews.org/courts/abortion-drug-access-misoprostol-louisiana-law-pregnancy-hemorrhage-risk/ Over the past decade, Louisiana hospitals began stocking specialized carts designed to treat hemorrhages, one of the most common pregnancy complications in the state. The plug-in cart can be wheeled from room to room and holds surgical tools and lifesaving medications to stem blood loss.

Medicaid Insurers’ Contracts on the Line in Tight Governor’s Race By Tony Leys July 30, 2026

https://kffhealthnews.org/health-industry/medicaid-insurer-contracts-iowa-governor-race/ One of America’s most competitive gubernatorial races could settle a heated argument over whether private insurance companies should run Medicaid.

A Native American woman stands outside in the late afternoon sun. The Newest Federally Recognized Tribe Wants Better Healthcare. It May Be On Its Own. By Andrew Jones July 31, 2026

https://kffhealthnews.org/rural-health/tribe-native-disparities-indian-health-service-federal-recognition-lumbee-north-carolina/ LUMBERTON, N.C. — Soybean fields surround Angie Lowery’s home in Robeson County, on a plot of rural land in southeastern North Carolina. Dozens of antique gas station signs, 20 feet tall, dominate her front yard. A framed re-creation of The Last Supper, Lone Ranger posters, and a 3-foot-wide tobacco harvesting basket adorn the walls of her home. A collector, Lowery over the years has amassed remnants of her region’s past.

Journalists Catch You Up on Fauci Hearing, Peptides, and Kids’ Caffeine Consumption Aug. 1, 2026

https://kffhealthnews.org/on-air/on-air-august-1-2026-fauci-hearing-fda-peptides-epa-grants-children-caffeine/

They Worked To Protect Public Health. Now They Want the Public’s Votes. By Phil Galewitz, Christine Mai-Duc, and Amanda Seitz July 31, 2026

https://kffhealthnews.org/elections/election-midterms-candidates-becerra-acton-el-sayed-california-ohio-michigan/ A handful of former public health officials are campaigning for top statewide offices across the country, testing whether their experience with covid and other hot-button health issues will appeal to voters in November.

Trump Administration Demands Hospitals Share Emergency Room Records By Amanda Seitz, Maia Rosenfeld, and Darius Tahir July 27, 2026

https://kffhealthnews.org/health-industry/cpsc-consumer-product-safety-commission-trump-er-injury-data-grab-neiss-konza/ The tiny federal agency that tracks consumer product safety is pressuring hospitals to turn over patient records from ER visits, including about injuries that have nothing to do with consumer products.

Health Research Funding Suddenly Cut: Dr. Aaron Carroll Explains Jeff ByersandAaron E. Carroll July 23, 2026

https://www.healthaffairs.org/do/10.1377/hp20260722.700568/full/?utm_campaign=podcast&utm_medium=email&_hsenc=p2ANqtz-9AsKtoD7Ln2Q6nYAqWOwIARNePpy6ObVbl4k_jK82IsJy7829qwtsiVbdfMLHTltiqltFfS_ZWooOs9IlkPjIPVMr9_g&_hsmi=431087453&utm_content=hatw&utm_source=well%20read

Cash Transfers And Child Health In The US: What Is Known And What Questions Remain Aditi Vasan,Meredith Matone,Jordan I. Wood,andRebecka Rosenquist July 16, 2026

https://www.healthaffairs.org/content/briefs/cash-transfers-and-child-health?utm_campaign=health%20policy%20brief&utm_medium=email&_hsenc=p2ANqtz--jvbzzb7ZlbPTUjdiveXflmID3Zcla3Ekfqf87KJh67bqNQbm10QbjEakJ7riOyGsB20Kt1S8kRocmfRLp5jl3vzC2dQ&_hsmi=431087453&utm_source=well%20read Key Points Cash transfer programs are a promising strategy for improving families’ economic security because of their relative simplicity and respect for individuals’ autonomy. Policy makers have increasingly also looked to cash transfers as a tool to improve child health. There are multiple mechanisms by which cash transfers could improve child health, including by increasing household income and enabling health-promoting investments, by reducing income instability and caregiver stress, and by strengthening social connections and building community trust. Recent evidence on cash transfers and child health is mixed. A large randomized controlled trial and a quasi-experimental study examining birthweight thresholds for Supplemental Security Income receipt both found no significant effects on child health. However, several studies of the 2021 expanded child tax credit showed that these payments were associated with small but significant improvements in birth outcomes. Some findings have been consistent across studies, including that parents tend to invest cash transfers in ways that promote child health and well-being. The divergent child health impacts observed across studies could be due to differences in payment timing, limited versus universal payments, focus population, and study design. Future research should examine these issues, selecting outcomes carefully and using both robust causal inference designs and community-engaged research methods. Cash transfers show promise in improving child health but should ideally complement, not replace, other evidence-based economic support programs. Policy makers should ground their decisions about these programs in findings that emerge consistently from rigorous research over time.

The 340B Rebate Fight Is Really Over Data Infrastructure Nobody Has Built Manasi Sudhir Salgaonkar July 15, 2026

https://www.healthaffairs.org/content/forefront/340b-rebate-fight-really-over-data-infrastructure-nobody-has-built?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz-8EDQ1qQmOnFatyJz-qURowgfmx_heLZR8_IMajKnDxKOKYN-_bWrebNSpywWGjLH31qTr6AMM6awC7Wpg7XmUjqDsEcQ&_hsmi=431087453&utm_source=well%20read Editor's Note: The article initially published on this page under the title "The 340B Rebate Fight Is Really A Fight Over Data Nobody Has Built" was taken down on July 30, 2026. Subsequent to publication, the author notified the editors about concerns with several interpretations in the article but declined offers to revise those interpretations. Also subsequent to publication, the editors learned that the author failed to disclose their primary employer IQVIA whose business is directly related to the subject matter discussed in the piece. This material omission compelled the editors to reevaluate the article and ultimately, due to the undisclosed conflict, remove it from the public record.

We Make For Poor Bandits: A Rural Pharmacist's Answer To The 340B 'Grift' John Mildenberger July 6, 2026

https://www.healthaffairs.org/content/forefront/we-make-poor-bandits-rural-pharmacist-s-answer-340b-grift?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz--com9vlH_66D3ubb2ft-Ufq7Sst099NbRRbvIzXYfCVk25BGdu26Uk5KlDBRJgNGXZlEiCCzTxlw2yCtwonOlfbS6juA&_hsmi=431087453&utm_source=well%20read Targeted transparency requirements, clearer guidance on contract pharmacy use, and stronger duplicate-discount safeguards would address 340B abuses without severing the lifeline that keeps rural and safety-net providers solvent.

Addressing Medical Affordability Without Compromising Care Ezekiel J. EmanuelandKevin A. Schulman July 9, 2026

https://www.healthaffairs.org/content/forefront/addressing-medical-affordability-without-compromising-care?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz-8Y7z9Ysaw_m8X8YL0ggf8HcTb-DFKglPe_wFNkH33c1jd1GU-9v-IHUV4LrWyd_PpdDQUyHMbEfHeakD0LKRIZkxsayQ&_hsmi=431087453&utm_source=well%20read The US spends 25 percent of all health care costs on administration, a big part of which involves billing for medical services. To realize savings requires standardizing and digitizing billing.

National Health Expenditure Projections, 2025–34: Strong Utilization Growth Initially, Legislative Impacts Later Authors: Jacqueline A. Fiore jacqueline.fiore@cms.hhs.gov, Andrea M. Sisko, John A. Poisal, Sheila D. Smith, Gigi A. Cuckler, Andrew J. Madison, Sean P. Keehan, Kathryn E. Rennie, and Nicholas J. Feehley

https://www.healthaffairs.org/doi/10.1377/hlthaff.2026.00642 By 2034, national health spending is projected to total nearly $9.0 trillion and to represent 20.6 percent of the economy, compared with $5.3 trillion and 18.0 percent in 2024. The rate of national health spending growth during this period is influenced by continued elevated use of medical services and goods through 2026; major legislative changes that affect insurance coverage and spending through 2028; and continued demographic shifts toward public programs, mainly Medicare. The insured share of the population is expected to be 90.5 percent in 2034, compared with 91.8 percent in 2024.

Spending, Prior Authorization, Health Equity, And More Authors: Donald E. Metz and The Editorial Staff

https://www.healthaffairs.org/doi/10.1377/hlthaff.2026.00906 This issue of Health Affairs includes articles on health care spending, nonprofit hospitals’ investment portfolios, prior authorization in Medicare Advantage, and health equity. We also present articles in our sponsored series Eye On The IRA, Age-Friendly Health, and The Practice Of Medicine, supported, respectively, by the National Pharmaceutical Council, the John A. Hartford Foundation, and the Physicians Foundation.

Access To Community Pharmacies Associated With Reduced Racial And Ethnic Disparities In Use Of Prescription Drugs, 2010–19 Authors: Maitreyi Sahu msahu1@bwh.harvard.edu, Tyler D. Wagner, Drew DeJarnatt, Haley Lescinsky, Meera Beauchamp, Sawyer W. Crosby, Kayla Taylor,

https://www.healthaffairs.org/doi/10.1377/hlthaff.2025.01459?utm_campaign=july%202026%20issue&utm_medium=email&_hsenc=p2ANqtz--NZWVetkDVWJLv18ufuQmOxtsbaZz0TjHy0esg2MeD94FFf65Yf-e1GRE8UG1hq4SZE57m_B47-3SxqWyLgcIWdgr4ZQ&_hsmi=431087453&utm_source=well%20read Racial and ethnic disparities in access to medicines persist across the US. Community pharmacies serve as critical access points for prescription drugs, yet their availability varies widely, potentially contributing to health disparities. We estimated the share of the population living within ten minutes of a community pharmacy across counties, by race and ethnicity, during the period 2010–23. We linked these measures to race and ethnicity–specific, state-level estimates of age- and prevalence-standardized medication use for twenty-seven health condition categories through 2019. A 1 percent increase in people living within ten minutes of a community pharmacy at the state level was associated with 0.7 percent higher use of medications per prevalent case. This association was strongest for Asian/Pacific Islander, Black, and Hispanic populations. In addition, a 1 percent increase in ten-minute community pharmacy access was associated with a 0.52 percent decrease in racial and ethnic disparities in medication use. These findings suggest that uneven community pharmacy access may exacerbate racial and ethnic disparities in medication use. Policy makers seeking to improve medication access should consider targeted interventions to preserve or expand pharmacy availability for underserved communities.

Workforce Projections For Physicians, Nurse Practitioners, And Physician Associates Authors: Monica O’Reilly-Jacob mo2986@cumc.columbia.edu, Lusine Poghosyan, Susan Kelly-Weeder, Sean Clarke, and David Auerbach

https://www.healthaffairs.org/doi/10.1377/hlthaff.2025.01747?utm_campaign=july%202026%20issue&utm_medium=email&_hsenc=p2ANqtz-8hgbOuFhR9Yoeg7AzXrlNyjr5vGFhrMzGrD-edssw4cmwx-Ouglg7Q4RacoUuZkFoKHxKC-H_ahnFtfsXJK4qZ7c0pUQ&_hsmi=431087453&utm_source=well%20read Ensuring an adequate supply of clinicians is a critical policy concern. In our forecast, physician supply growth remains consistent with prior forecasts, at 1 percent annually, but the numbers of nurse practitioners and physician associates, respectively, are projected to increase 11 percent and 5.6 percent annually through 2030. The surge in nurse practitioner graduates, especially, has implications for onboarding, team-based care, and policies.

Trends In US Health Care Spending By Income, 2005–23 Authors: Betsy Q. Cliff bqcliff@uchicago.edu and Giacomo Meille

https://www.healthaffairs.org/doi/10.1377/hlthaff.2025.01325?utm_campaign=july+2026+issue&utm_medium=email&_hsenc=p2ANqtz-8Urjj3j5NShfemaiwCg0_AgkXA7qUgR57BHRd10e_iPxvd3eCL-KnRaNQGdSFjUiNS6z1qCbLJH8xgpgOovrDCqk5-8g&_hsmi=431087453&utm_source=well+read From 2005 to 2023, per capita health care spending was highest and grew most rapidly among Americans in the top income quintile. During this period, age- and health-adjusted real spending grew 1.8 percent per year among people in the highest income quintile compared with no growth among people in the lowest income quintile. Differences among income levels were most prominent in outpatient services and prescription drugs.

We once praised the American Diabetes Association’s courage. How things have changed The ADA must take accountability for a self-made mess

https://www.statnews.com/2026/07/31/american-diabetes-association-ada-police-apology-independence/ By Adam Marcus and Ivan OranskyJuly 31, 2026 Marcus is the editorial director of the Center for Scientific Integrity, the parent nonprofit of Retraction Watch, and senior editorial director of primary care at Medscape. Oransky is the executive director of the center and distinguished journalist in residence at New York University’s Arthur Carter Journalism Institute.

Trump administration revises rebate pilot for 340B drug discount program, angering hospitals HRSA says pilot will improve transparency by providing greater visibility into 340B transactions

https://www.statnews.com/pharmalot/2026/07/31/trump-administration-revises-rebate-pilot-drug-discount-program-hospitals/ By Ed SilvermanJuly 31, 2026 Pharmalot Columnist, Senior Writer

Syphilis spreads while researchers contend with federal constraints and a drug shortage End to cross-border collaboration makes infections easier to miss By Eric BoodmanJuly 31, 2026

https://www.statnews.com/2026/07/31/syphilis-drug-shortage-case-study-san-diego-patient-researcher-advocate/

Hiroshima at 81: America’s new nuclear bomb, a buried Iranian target, and a question no one wants to ask Henry Miller | July 30, 2026

https://geneticliteracyproject.org/2026/07/30/hiroshima-at-81-americas-new-nuclear-bomb-a-buried-iranian-target-and-a-question-no-one-wants-to-ask/ August 6 is one of the most consequential and emotional anniversaries for Americans, our World War II allies, and Japan—each for different reasons. The Manhattan Project—which developed the two atomic bombs dropped on Hiroshima and Nagasaki in Japan in 1945—was a monumental scientific and technological achievement. The bombs ended the war and saved millions of lives of combatants and civilians.

Bowing to Congressional pressure, Kennedy reverses himself and releases $600 million that helps developing countries buy and distribute vaccines Carmen Paun | Politico | July 30, 2026

https://geneticliteracyproject.org/2026/07/30/bowing-to-congressional-pressure-kennedy-reverses-himself-and-releases-600-million-that-helps-developing-countries-buy-and-distribute-vaccines/ The departments of State and Health and Human Services confirmed [on July 29, 2026] they are releasing $600 million Congress appropriated to an international partnership that helps developing countries buy and distribute vaccines.

After muzzling RFK, Jr. over autism-vaccine conspiracy theories, Trump defies aides to push scares again Melody Schreiber | The Guardian | July 30, 2026

https://geneticliteracyproject.org/2026/07/30/after-muzzling-rfk-jr-over-autism-vaccine-conspiracy-theories-trump-defies-aides-to-push-scares-again/

Fear, science, and the law: If talc powder is unlikely to cause cancer and J&J was winning in court, why did it pay more than $5.5 billion to settle? Surya Prakash Josyula | Telugu Times | July 30, 2026

https://geneticliteracyproject.org/2026/07/30/fear-science-and-the-law-if-talc-powder-is-unlikely-to-cause-cancer-and-jj-was-winning-in-court-why-did-it-pay-more-than-5-5-billion-to-settle/ It is one of the strangest corporate stories in recent history. Johnson & Johnson won most of the major talc cases that went to trial. Yet, after fighting for nearly 12 years, the healthcare giant agreed to pay $5.5 billion to settle the remaining lawsuits.

AI-generated physicians promoting bogus cures and worthless supplements surge on social media Joe Pinner | The Guardian | July 31, 2026

https://geneticliteracyproject.org/2026/07/31/ai-generated-physicians-promoting-bogus-cures-and-worthless-supplements-surge-on-social-media/ Misleading health claims online pose a “huge danger to public safety”, experts have warned, after research has shown that AI-generated doctors are gaining millions of views on TikTok by spreading dubious health advice.

Climate scientists claim conservative activists are promoting ‘lies’ that Europe’s summer heatwaves are far from unusual Estelle Nilsson-Julien, Tamsin Paternoster | Euronews | July 31, 2026

https://geneticliteracyproject.org/2026/07/31/climate-scientists-claim-conservative-activists-are-promoting-lies-that-europes-summer-heatwaves-are-far-from-unusual/ From debunking claims that cold winters do not act as proof that global warming is fake to allegations that the climate changes naturally and so mankind is not to blame, scientists have spent decades proving the very existence of the climate crisis.

How Kennedy and his family could pocket millions from Merck’s $50 million vaccine injury settlement that he oversaw Kate Gibson | CBS News | July 31, 2026

https://geneticliteracyproject.org/2026/07/31/how-kennedy-and-his-family-could-pocket-millions-from-mercks-50-million-vaccine-injury-settlement-that-he-oversaw/ Kennedy for years has earned referral fees from Wisner Baum, a Los Angeles personal injury law firm that is currently suing Merck, alleging the pharmaceutical giant failed to properly warn the public about risks from its vaccine against human papillomavirus (HPV), Gardasil ….

Viewpoint: Are the U.S. and Europe headed towards a repudiation of agricultural biotechnology red tape? Emily Bass | July 28, 2026

Viewpoint: Are the U.S. and Europe headed towards a repudiation of agricultural biotechnology red tape? Emily Bass | July 28, 2026 https://geneticliteracyproject.org/2026/07/28/viewpoint-are-the-u-s-and-europe-headed-towards-a-repudiation-of-agricultural-biotechnology-red-tape/ 2026 may well be remembered as the year global agriculture began to untangle itself from decades of precautionary red tape. Earlier this year, the agricultural biotechnology landscape shifted in two places that have long defined opposite poles of the regulatory debate: the European Union, historically the home of exceedingly precautionary biotech rules, and the United States, a pro-innovation leader now eyeing a massive regulatory overhaul.

FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory, and Submission Updates Tuesday, September 29, 2026 AGENDA

https://www.fda.gov/media/193623/download?utm_medium=email&utm_source=govdelivery Join SBIA as FDA shares the latest updates on registration and listing submissions, including current validation rules, and walks through the evolving regulatory requirements and compliance framework that shape how industry engages with these processes. We'll also dive into compliance strategies for drug amount reporting requirements — a great opportunity to ask questions and hear directly from those working at the forefront of these issues. FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates September 29, 2026 https://www.fda.gov/drugs/news-events-human-drugs/fdas-drug-registration-and-listing-workshop-compliance-regulatory-and-submission-updates-09292026?utm_medium=email&utm_source=govdelivery

Expedited IND Pilot Program Educational Webinar for Stakeholders August 6, 2026

https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/expedited-ind-pilot-program-educational-webinar-stakeholders-08062026?utm_medium=email&utm_source=govdelivery Expedited IND Pilot Program Educational Webinar for Stakeholders August 6, 2026, 9:00 a.m. - 10:00 a.m. ET The Food and Drug Administration is announcing an educational webinar on a proposal to establish the Expedited Investigational New Drug (IND) pilot program, a new program meant to accelerate the time from drug identification to first-in-human (FIH) clinical trial. The potential pilot program which would establish a network of qualified research institutions, such as academic medical centers (AMCs), healthcare networks (HNs), contract research organizations (CROs), regulatory advisors, and/or other research or third-party review organizations (collectively called Qualified Research Institutions, or “QRIs”), who would partner with sponsors to develop and review protocols for FIH clinical trials intended for a IND submission to FDA. FDA is holding this webinar to clarify the intent behind the program, the purpose of the RFI, and answer specific stakeholder questions that might influence your feedback on the RFI. Submit Comments Comments on the Expedited Investigational New Drug Pilot Program must be submitted on or before 11:59 p.m. Eastern Time at the end of August 24, 2026. Submit electronic comments on https://www.regulations.gov to docket FDA-2026-N-4699. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. For additional information, see Federal Register :: Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period. https://unblock.federalregister.gov/

Learning from a decade of progress in amyloidosis The Lancet +... + +

Learning from a decade of progress in amyloidosis The Lancet https://www.thelancet.com/journals/lancet/issue/vol408no10553/PIIS0140-6736(26)X2028-1 What can psychiatrists expect from the next DSM? Niall Boyce https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01077-9/abstract?dgcid=raven_jbs_etoc_feature_lancet Systemic light chain and transthyretin amyloidosis—treatment advancements and future directions Giada Bianchi, MDa,b Send email to giada_bianchi@dfci.harvard.edu ∙ Prof Vaishali Sanchorawala, MDc ∙ Prof Ashutosh Wechalekar, MDd ∙ Martha Grogan, MDe ∙ Sarah A M Cuddy, MDa,b,f ∙ Prof Giampaolo Merlini, MD https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00302-8/abstract?dgcid=raven_jbs_etoc_feature_lancet

Vision 2040 in Japan: renewing UHC through community-based health care and health security The Lancet Regional Health – Western Pacific +... + +

https://www.thelancet.com/journals/lanwpc/issue/vol72nonull/PIIS2666-6065(26)X2005-3 Japan's health system toward 2040: structural challenges and a renewed social contract Lisa Yamasakia,b ∙ Haruka Sakamotoc ∙ Hideki Hashimotod ∙ Naoki Kondoe ∙ Osamu Kuniif ∙ Yusuke Tsugawag ∙ et al. https://www.thelancet.com/journals/lanwpc/article/PIIS2666-6065(26)00124-0/fulltext?dgcid=raven_jbs_etoc_feature_lanwpc Comparison of sitafloxacin monotherapy versus doxycycline plus rifampicin for acute uncomplicated human brucellosis: a multicenter, randomized, open-label, non-inferiority trial Chunmei Qua,b,f,g ∙ Qingqing Xuc,f,g ∙ Tianyi Wua,b ∙ Minhe Xud ∙ Xia Gaod ∙ Zhongrong Lud ∙ et al. https://www.thelancet.com/journals/lanwpc/article/PIIS2666-6065(26)00111-2/fulltext?dgcid=raven_jbs_etoc_feature_lanwpc

Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts July 2026 ++

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biosimilar-and-interchangeable-biosimilar-products-considerations-container-closure-systems-and?utm_medium=email&utm_source=govdelivery FDA Issues Draft Guidance for Industry, “Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts” Today, FDA released a draft guidance for industry “Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts.” In this draft guidance, FDA outlines its recommendations for proposed biosimilar and interchangeable biosimilar products regarding the development of container closure systems (e.g., vials) and device constituent parts of combination products (e.g., delivery devices that contain the biological product such as prefilled syringes and autoinjectors). This draft guidance expands on and clarifies the Agency’s recommendations and expectations regarding the development of delivery devices and container closure systems described in Q.I.4 of the guidance for industry titled “Questions and Answers on Biosimilar Development and the BPCI Act” and the guidance for industry titled “Considerations in Demonstrating Interchangeability With a Reference Product.” Available guidance regarding the development of delivery devices and container closure systems was limited in scope and did not provide detailed recommendations regarding the human factors related considerations for proposed biosimilar and interchangeable biosimilar products. This draft guidance addresses these gaps and describes a framework for the types of data and information that may be necessary to support licensure as a biosimilar or interchangeable biosimilar product. This draft guidance supports FDA’s efforts to promote competition, reduce biosimilar and interchangeable biosimilar development costs, decrease regulatory burden, and increase patient access to biologic medications while ensuring that differences in container closure systems or devices do not compromise safety or effectiveness. This action also relates to FDA's BsUFA III commitment to issue guidance on this topic. For instructions on how to submit comments on the draft guidance, see the Federal Register Notice. For more information about biosimilars visit: www.fda.gov/biosimilars Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry March 2026 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-biosimilar-development-and-bpci-act?utm_medium=email&utm_source=govdelivery

Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry July 2026 ++

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-adhesion-transdermal-and-topical-delivery-systems-andas On August 3rd, the Food and Drug Administration (FDA) will publish a final and revised draft guidance related to the design and conduct of studies for evaluating transdermal and topical delivery systems (TDS) submitted in supported of abbreviated new drug applications (ANDAs). These publications, which apply to TDS products submitted in ANDAs, include the following: The final guidance for industry entitled, “Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs.” Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry | FDA This guidance finalizes the draft guidance for industry of the same title which was announced in the Federal Register on April 13, 2023 (88 FR 22456). FDA received no comments on the revised draft guidance (Revision 2) and, thus, no comments were considered before publication of this guidance. This final guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic endpoints). FDA recommends that applicants consult this guidance in conjunction with any relevant product-specific guidances for industry when considering the design and conduct of studies that may be appropriate to support the BE of a proposed generic TDS product to its reference listed drug and/or reference standard product. FDA also recommends that an applicant who seeks to use an alternative approach to FDA’s recommendations for the design and conduct of studies evaluating the adhesion performance of a TDS contact the Agency to discuss the proposed alternative approach to evaluate adhesion performance for that particular drug product. As part of the Drug Competition Action Plan, FDA is publishing this final guidance to increase competition in the marketplace for prescription drugs, facilitate the entry of high-quality and affordable generic drugs, and improve public health. This guidance finalizes the draft guidance for industry of the same title issued on April 13, 2023. This final guidance assists applicants with the design and conduct of studies evaluating the adhesion performance of a TDS by providing clear information that will reduce duplicative efforts, regulatory delays, and process uncertainties for industry. It also streamlines FDA's application review process, resulting in efficient and timely reviews. By saving time and resources that lead to faster approval of generic products, the American public will see more treatment options and cost savings. The revised draft guidance for industry entitled, “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.” Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs | FDA This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an ANDA. The revised draft guidance is intended to clarify FDA’s recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization studies. As part of the Drug Competition Action Plan, FDA is publishing this revised draft guidance to increase competition in the marketplace for prescription drugs, facilitate the entry of high-quality and affordable generic drugs, and improve public health. This revised draft guidance replaces the April 2023 draft guidance of the same name. This revised draft guidance assists applicants by providing clear information that will reduce duplicative efforts, regulatory delays, and process uncertainties for industry, as well as time spent by FDA reviewing applications. By saving time and resources that lead to faster approval of generic products, providing the American public with more treatment options and cost savings. Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry July 2026 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-irritation-and-sensitization-potential-transdermal-and-topical-delivery-systems-andas?utm_medium=email&utm_source=govdelivery

Ex-Mayo Exec Sues, Says She Was Fired for Whistleblowing on AI Security, Privacy Randy Dotinga

https://www.medscape.com/viewarticle/ex-mayo-exec-sues-says-she-was-fired-whistleblowing-ai-2026a1000ps1?src= A former director who oversaw research at the Mayo Clinic accuses the healthcare system of retaliation after she raised the alarm about “fundamental lapses” in evaluating AI tools for patient care and research. https://www.medscape.com/index/list_15056_0

Manufacturers Report $2.6 Billion in Open Payments to Physicians, but Product Details Remain Murky Steph Weber

https://www.medscape.com/viewarticle/manufacturers-report-2-6-billion-open-payments-physicians-2026a1000pxt Drug and medical device makers reported approximately $2.6 billion in payments to more than 665,000 physicians through the Open Payments program in 2025, according to a new analysis of federal data. The manufacturers paid an additional $1.3 billion to teaching hospitals and nonphysician practitioners, bringing total spending to about $3.9 billion, an 18.4% increase from the previous year.

US Senate Panel Advances Trump CDC Pick Schwartz Ahmed Aboulenein

https://www.medscape.com/s/viewarticle/us-senate-panel-votes-advance-nomination-trump-cdc-pick-2026a1000q0v WASHINGTON, July 30 (Reuters) - The U.S. Senate health committee voted on Thursday to advance the nomination of President Donald Trump's pick for CDC director ⁠Dr. Erica Schwartz, handing his administration a rare win after repeated failed attempts to fill top health posts.

Is It Ethical for Doctors to Hawk Products in the Office? Lambeth Hochwald

https://www.medscape.com/viewarticle/it-ethical-doctors-hawk-products-office-2026a1000q0w Your patient is checking out at the dermatologist’s office. Copay? Check. Next appointment? Check. Can we show you our skincare supplements? Come again? For some physicians, the prospect of selling vitamins, supplements, ointments, or skincare products in the office may make sense: It’s easy to explain the benefits of a product when it’s on hand, and it’s convenient for patients to buy what their doctor recommends — on the way out the door.

Doctors Aren’t Asking for More Money; They’re Asking for Their Lives Back Jennifer Nelson

https://www.medscape.com/viewarticle/doctors-arent-asking-more-money-theyre-asking-their-lives-2026a1000p4t?ecd=WNL_physrep_260731_MSCPEDIT_dc-mental-health_etid8553101&uac=148436CN&impID=8553101 Nearly 6 in 10 physicians recently surveyed said they’d be willing to take a pay cut in exchange for better work-life balance — a finding that may say as much about the state of medicine as any burnout statistic.

Europe’s tentative embrace of agricultural gene editing could revolutionize food production and health in Asia Arif Hossain | Dhaka Tribune | July 28, 2026

https://geneticliteracyproject.org/2026/07/28/europes-tentative-embrace-of-agricultural-gene-editing-could-revolutionize-food-production-and-health-in-asia/

Prioritizing AI, robotics, and nuclear energy: Trump administration is guiding research funding away from independent universities to private companies Christopher Flavelle, Sheryl Gay Stolberg | New York Times | July 28, 2026

https://geneticliteracyproject.org/2026/07/28/prioritizing-ai-robotics-and-nuclear-energy-trump-administration-is-guiding-research-funding-away-from-independent-universities-to-private-companies/

Viewpoint: RFK, Jr.’s depressingly misguided (and litigator-funded) crusade against antidepressants Aaron Carroll | Washington Post | July 28, 2026

https://geneticliteracyproject.org/2026/07/28/viewpoint-rfk-jr-s-depressingly-misguided-and-litigator-funded-crusade-against-antidepressants/

The PEPTIDE-L Wave Rolls On! PCAC Adds Two More Bulk Drug Substances for the 503A List July 28, 2026 By Charles D. Snow & Karla L. Palmer & Mary Bass —

https://www.thefdalawblog.com/2026/07/the-peptide-l-wave-rolls-on-pcac-adds-two-more-bulk-drug-substances-for-the-503a-list/?utm_source=rss&utm_medium=rss&utm_campaign=the-peptide-l-wave-rolls-on-pcac-adds-two-more-bulk-drug-substances-for-the-503a-list Well, don’t say we didn’t tell you what was coming. Day 2 of the Pharmacy Compounding Advisory Committee (PCAC or the Panel) Meeting (mostly) followed in the footsteps and at the pace of Day 1 (see our prior coverage of Day 1). Over the course of the day, the Panel worked through three more nominated peptides for possible inclusion on the Section 503A bulk drug substances list, ultimately recommending two—Epitalon and Semax—for inclusion, while declining to recommend Emideltide (the delta sleep-inducing peptide, aka “DSIP”). Was the DSIP “no-vote” the sacrificial lamb here? As on Day 1, the real drama was less in the vote counts than in the recurring, and still-unresolved, question that FDA pressed from the outset: When a prescriber writes a prescription for one of these peptides, does anyone actually know what the patient is receiving?

Number of Measles Cases Roars Past Last Year's Total As Vaccine Hesitancy Takes Hold

Number of Measles Cases Roars Past Last Year's Total As Vaccine Hesitancy Takes Hold A little more than halfway through the year, the United States has already confirmed more cases — 2,318 — than it had in 2025. Public health experts say a full-throated vaccination push at the national level would stem the tide in cases but acknowledge that seems unlikely under the current administration. Plus, the latest on rising cyclosporiasis cases. https://kffhealthnews.org/morning-briefing/monday-july-27-2026/

Cyclospora Boosts Fears That Worse Foodborne Outbreaks Are Ahead

Cyclospora Boosts Fears That Worse Foodborne Outbreaks Are Ahead The recent outbreak of a foodborne parasite sickened thousands and hospitalized hundreds across the U.S. before federal investigators identified the suspected source. Food safety experts say cuts to the public health system hobbled the response — and that the next outbreak could be much worse. ( Kate Wells and Stephanie Armour , 7/28 ) https://kffhealthnews.org/latest-morning-briefing/

Trump Administration Demands Hospitals Share Emergency Room Records By Amanda Seitz, Maia Rosenfeld, and Darius Tahir July 27, 2026

https://kffhealthnews.org/health-industry/cpsc-consumer-product-safety-commission-trump-er-injury-data-grab-neiss-konza/ A tiny federal agency tasked with protecting the public from injuries caused by lawn mowers and coffeemakers is demanding that some of the nation’s biggest health systems turn over detailed, personally identifiable medical records of all patients who seek help at their emergency rooms.

Federal Loan Caps Add Barriers — And Likely Debt — for Healthcare Students

https://kffhealthnews.org/news/wamu-health-hub-federal-loan-caps-healthcare-careers-student-debt/ KFF Health News: Federal Loan Caps Add Barriers — And Likely Debt — For Healthcare Students The federal government is capping the amount graduate students can borrow. The Department of Education says the new rules are designed to help curb student debt and pressure schools to lower tuition. But some loan experts fear those good intentions could leave many at the mercy of private lenders with higher interest rates. Saddling healthcare graduate students with pricier debt burdens can narrow their career choices. (Sausser, 7/28)

Newsom Reverses on Long-Sought Paid Leave Benefit for Teachers in California By Annie Sciacca July 28, 2026

https://kffhealthnews.org/elections/newsom-california-teacher-paid-maternal-pregnancy-leave-reversal/ California public school teacher Mollie Blustein planned her pregnancy so that her daughter would arrive during summer break. But when the elementary school teacher went into premature labor and delivered her baby two weeks before the end of school, she faced another stressor: a huge pay cut. KFF Health News: Newsom Reverses On Long-Sought Paid Leave Benefit For Teachers In California California public school teacher Mollie Blustein planned her pregnancy so that her daughter would arrive during summer break. But when the elementary school teacher went into premature labor and delivered her baby two weeks before the end of school, she faced another stressor: a huge pay cut. The majority of California’s roughly 300,000 teachers don’t have access to the state-funded paid leave program that most new parents in the private sector do. Instead, many local school districts deduct the cost of a substitute teacher from educators’ pay during parental leave. (Sciacca, 7/28)

Cyclospora Boosts Fears That Worse Foodborne Outbreaks Are Ahead By Kate Wells and Stephanie Armour July 28, 2026

https://kffhealthnews.org/public-health/cyclospora-outbreak-foodborne-monitoring-cdc-fda-trump-cuts-michigan/ The recent outbreak of a foodborne parasite sickened thousands and hospitalized hundreds across the U.S. before federal investigators identified the suspected source. Food safety experts say cuts to the public health system hobbled the response — and that the next outbreak could be much worse.

How Many Uninsured Are in the Coverage Gap and How Many Could be Eligible if All States Adopted the Medicaid Expansion? Authors: Sammy Cervantes, Clea Bell, Jennifer Tolbert, and Anthony Damico Published: Jul 27, 2026

https://www.kff.org/medicaid/how-many-uninsured-are-in-the-coverage-gap-and-how-many-could-be-eligible-if-all-states-adopted-the-medicaid-expansion/ This analysis estimates that 1.4 million uninsured individuals in the ten states without Medicaid expansion, including many working adults, people of color, and those with disabilities, remain in the "coverage gap," ineligible for Medicaid or for tax credits that would make coverage affordable through the Affordable Care Act's Marketplaces.

Donor Government Funding for HIV Drops by $2.1 Billion in 2025 Due to Declines in Funding from the United States, Marking Largest Annual Decrease Since Scale-up for the HIV Response Began Published: Jul 27, 2026

https://www.kff.org/global-health-policy/donor-government-funding-for-hiv-drops-by-2-1-billion-in-2025-due-to-declines-in-funding-from-the-united-states-marking-largest-annual-decrease-since-scale-up-for-the-hiv-response-began/ Donor government funding to combat HIV in low- and middle-income countries fell by $2.1 billion in 2025, a 25% decrease from the previous year, according to a new report by KFF and the Joint United Nations Programme on HIV/AIDS (UNAIDS). Total disbursements dropped to $6.2 billion in 2025, down from $8.3 billion in 2024, marking the largest single-year decline since donor funding scale-up

Donor Government Funding for HIV in Low- and Middle-Income Countries in 2025 Authors: Adam Wexler, Jennifer Kates, and Stephanie Oum Published: Jul 27, 2026

https://www.kff.org/global-health-policy/donor-government-funding-for-hiv-in-low-and-middle-income-countries-in-2025/ This report provides an analysis of donor government funding to address the HIV response in low- and middle-income countries in 2025, the latest year available, as well as trends over time. It includes both bilateral funding from donors and their multilateral contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), UNITAID, and Joint United Nations Programme on HIV/AIDS (UNAIDS).

KFF Health Tracking Poll: Ebola & Pandemic Preparedness Authors: Lunna Lopes, Isabelle Valdes, Audrey Kearney, Mardet Mulugeta, and Liz Hamel Published: Jul 28, 2026

https://www.kff.org/public-opinion/kff-health-tracking-poll-ebola-pandemic-preparedness/ Much of the public has yet to form an opinion on the U.S. government’s response to the Ebola outbreak in the Democratic Republic of the Congo, this poll finds. Four in ten adults say the U.S. is less prepared for a pandemic now than it was in 2020.

How Has ACA Marketplace Enrollment Changed Across States in 2026? Authors: Justin Lo, Matt McGough, and Cynthia Cox Published: Jul 28, 2026

https://www.kff.org/affordable-care-act/how-has-aca-marketplace-enrollment-changed-across-states-in-2026/ Following several years of rapid enrollment growth in the Affordable Care Act (ACA) Marketplaces that corresponded with temporary enhanced premium tax credits, enrollment fell for the first time in seven years in 2026, when those tax credits expired. Every state except for New Mexico saw a drop in ACA Marketplace enrollment from 2025 to 2026. State-based Marketplaces that run their own enrollment platforms, including those that partially offset the expiring federal enhanced tax credits, generally…

Comparing U.S. Ebola Outbreak Response Capabilities and Practices Over Time Authors: Josh Michaud and Jennifer Kates Published: Jul 28, 2026

https://www.kff.org/global-health-policy/comparing-u-s-ebola-outbreak-response-capabilities-and-practices-over-time/?utm_campaign=KFF-Global-Health-Policy&utm_medium=email&_hsenc=p2ANqtz-_4_mg6ApbNggnN2nnWRA5ZfKhpuNEA7dN6Q1w7JMVmr06wF6MPgCw3KAjXVrDHBwjBsA9X6g2tpDMRm74cSw-O3tOscw&_hsmi=430464226&utm_content=430464226&utm_source=hs_email Analysis Compares the U.S. Response to the Current Ebola Outbreak to Past Ones A new KFF analysis compares the Trump administration’s response to the ongoing Ebola outbreak in the Democratic Republic of Congo – the most significant international infectious disease outbreak of its second term – to earlier outbreaks during the Obama administration and first Trump administration. While the current administration significantly altered the structure of the U.S. global health response, the analysis shows that the speed of the response is on par with the prior two outbreaks. In addition, the U.S. pledge of $375 million during the first two months of the current outbreak already exceeds funding levels during the prior outbreaks. At the same time, there are still many unknowns about the U.S. response and there are distinctions from the past, including lack of formal coordination with the World Health Organization, significant changes in U.S. global health efforts, including funding reductions, and a more restrictive domestic border protection approach. The analysis includes a detailed side-by-side comparison of the U.S. response to each of the three Ebola outbreaks, including funding levels, staff deployments, research support, communications practices, multilateral engagement, domestic border protection measures, and organizational structure. It also includes background on the scope of the three outbreaks and pre-existing U.S. global health engagement in affected countries. KFF is also releasing new polling that shows much of the public has yet to form an opinion on the U.S. government’s response to the outbreak. When it comes to preventing an Ebola outbreak in the U.S., people are more likely to say that the U.S. is not doing enough (38%) than say it is doing enough (23%). This reflects a wide partisan gap in perceptions, with a majority of Democrats saying the U.S. is not doing enough to prevent an outbreak in the U.S. Republicans are more than twice as likely to say the government is doing enough than not doing enough, while the reverse is true for independents. The poll also gauges the public’s views on the nation’s preparedness for a major pandemic. Four in 10 adults (40%) say the U.S. is less prepared now than it was in 2020 when COVID-19 hit. That is up from one in four (26%) who said the same in January 2025 shortly before the start of President Trump’s second term. This again reflects a wide partisan divide. Contact: Craig Palosky | 202.654.1369 | CraigP@kff.org

Business of Medicine +...

https://www.medscape.com/businessmedicine FemTech’s Biggest Test: Can It Deliver on Its Promise? Maria Cristina Valsecchi https://www.medscape.com/viewarticle/femtechs-biggest-test-can-it-deliver-its-promise-2026a1000pmp July 28, 2026 For decades, the hormonal fluctuations that characterize the female reproductive cycle have been viewed as a confounding factor, contributing to the exclusion or underrepresentation of women in preclinical and clinical research. Today these same fluctuations are increasingly recognized as a valuable source of information about women’s overall health.

Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications June 23, 2026

Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications https://www.fda.gov/drugs/news-events-human-drugs/office-new-drugs-standard-safety-tables-and-figures-new-drug-and-biologic-applications-06232026?utm_medium=email&utm_source=govdelivery

FDA/Center for Research on Complex Generics (CRCG) Workshop on Navigating the GLP-1 Generic Drug Pathway September 23 - 24, 2026

https://www.fda.gov/drugs/news-events-human-drugs/fdacenter-research-complex-generics-crcg-workshop-navigating-glp-1-generic-drug-pathway-09232026?utm_medium=email&utm_source=govdelivery Are you looking to deepen your understanding of regulatory science, innovative analytical approaches, and development strategies for generic GLP-1 drug products? This 2-day hybrid workshop brings together FDA, industry, consulting groups and academic experts to address regulatory challenges and to explore the latest scientific advancements shaping the development of generic GLP-1 products across diverse therapeutic areas. Through a series of presentations and interactive discussions, participants will examine regulatory pathways and clinical contexts for generic GLP-1 products, explore characterization and sameness demonstration strategies, and delve into recombinant peptide manufacturing and host cell impurity characterization and control. The program will also address critical challenges such as Product-Specific Guidance (PSG) development, bioequivalence study design and quality expectations for oral and injectable generic GLP-1 products, device user interface evaluation and considerations for supporting other design differences, and drug-device integration and submission coordination, equipping attendees with the knowledge needed to navigate the regulatory landscape. Choose your experience: Virtual: Access expert presentations and panel discussions from anywhere. In-person: Interact directly with experts from industry, consulting groups, academia and FDA to understand current practices and challenges, regulatory expectations, and emerging trends. Registration fee applies. The in-person component will take place at The Universities at Shady Grove, Rockville, MD. High-engagement scientific interactions will be facilitated through two in-person-only sessions: A session dedicated to informal networking and candid dialogue among subject matter experts about scientific and regulatory challenges for generic GLP-1 products including sections focused on: Device constituents of drug-device combination products Impurities and immunogenicity GLP-1 characterization and sameness Orally administered peptides A guided session for small groups to elucidate and work through specific challenging issues for generic GLP-1 products development and assessment. Don’t miss this opportunity to advance your expertise, network with leading professionals, and help shape the future of generics. For more information, visit https://www.complexgenerics.org/education-training/navigating-the-glp-1-generic-drug-pathway/

Oncology Center of Excellence Guidance Documents

https://www.fda.gov/about-fda/oncology-center-excellence/oncology-center-excellence-guidance-documents?utm_medium=email&utm_source=govdelivery Today, the FDA’s Oncology Center of Excellence is announcing three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs. Fewer than 5% of cancer patients currently receiving treatment are enrolled in clinical trials even though more than 70% say they are willing to participate. The guidance documents address one reason for low participation – stringent and complex clinical trial eligibility criteria. “Unnecessarily restrictive eligibility criteria may slow subject accrual, limit patients’ access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug,” the three guidances say in their preambles. Each document focuses on a specific area where rigid eligibility criteria limit participation including: • Defining who is too sick to participate. The final guidance Cancer Clinical Trial Eligibility Criteria: Performance Status Guidance for Industry, IRBs, and Clinical Investigators raises questions about the use of the common yardstick known as “performance status,” a measure of how well a patient is able to perform ordinary tasks and carry out activities of daily living. Some patients may have a low performance status because cancer has made them sick, but this status could improve once the patient is enrolled in the trial, the guidance says. • Deciding when patients should be excluded if they are taking other medications. The final guidance Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications Guidance for Industry, IRBs, and Clinical Investigators encourages sponsors to consider whether time based “washout periods” are necessary between stopping one cancer drug and beginning the experimental drug and also makes some allowances for patients taking other medications. • Determining the appropriate laboratory value for test results that determine trial eligibility. The final guidance Cancer Clinical Trial Eligibility Criteria: Laboratory Values Guidance for Industry, IRBs, and Clinical Investigators discusses taking a more scientific and safety-focused approach to tests commonly used to determine whether a patient might qualify to participate in a clinical trial. The three guidance documents advance one of the goals of HHS’ Operation Trialblazer Initiative, a coordinated federal initiative designed to accelerate drug development and reclaim America’s edge in clinical research. The Trialblazer Roadmap, released in late June, tasked the FDA with Improving patient and participant access and engagement in clinical trials. The documents are part of a series of guidances developed as a result of workshops with Friends of Cancer Research and the American Society of Clinical Oncology.

FDA Virtual Workshop on Digital Health Technologies and Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials August 27, 2026

https://www.fda.gov/drugs/news-events-human-drugs/fda-virtual-workshop-digital-health-technologies-and-statistical-considerations-digitally-derived?utm_medium=email&utm_source=govdelivery FDA Virtual Workshop on Digital Health Technologies and Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials Date: Thursday, August 27, 2026; 9:30 a.m. - 3:45 pm ET The FDA is hosting a free virtual public workshop, convened by the Duke-Margolis Institute for Health Policy under a cooperative agreement with the FDA, to discuss statistical considerations for digitally-derived endpoints in clinical trials for drug and biological products. https://healthpolicy.duke.edu/events/statistical-considerations-digitally-derived-endpoints-clinical-trials

Cancer Clinical Trial Eligibility Criteria: Performance Status Guidance for Industry, IRBs, and Clinical Investigators July 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-performance-status?utm_medium=email&utm_source=govdelivery

Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications Guidance for Industry, IRBs, and Clinical Investigators July 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-washout-periods-and-concomitant-medications?utm_medium=email&utm_source=govdelivery

Cancer Clinical Trial Eligibility Criteria: Laboratory Values Guidance for Industry, IRBs, and Clinical Investigators July 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-laboratory-values?utm_medium=email&utm_source=govdelivery

Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program?utm_medium=email&utm_source=govdelivery FY 2026 Small Business Applications Close August 1 — FY 2027 Applications Open Immediately After If you are interested in applying to the MDUFA Small Business Determination Program, please read this important update about upcoming application deadlines. FY 2026 Deadline: August 1, 2026, at 4:00 PM ET The deadline to submit a FY 2026 MDUFA Small Business Request is 4:00 PM ET on August 1, 2026. FY 2026 determinations are effective from October 1, 2025, through September 30, 2026. Applications submitted after 4:00 PM ET on August 1, 2026, will not be accepted for FY 2026. If you plan to submit a medical device application during FY 2026 and are seeking a reduced fee or waiver, you must have your small business determination before you submit your device application. Do not submit your device application until you have received your small business determination from FDA. FY 2027 Applications Open: August 1, 2026, at 4:01 PM ET The application window for FY 2027 MDUFA Small Business Requests opens at 4:01 PM ET on August 1, 2026. FY 2027 covers October 1, 2026, through September 30, 2027. Applications submitted before 4:01 PM ET on August 1, 2026, will not be accepted for FY 2027. How to Apply All Small Business Requests must be submitted electronically through the CDRH Portal. Step-by-step instructions are available on the Reduced Medical Device User Fees: Small Business Determination (SBD) Program page. As stated in FDA's guidance, Medical Device User Fee Small Business Qualification and Determination (issued July 31, 2025), FDA accepts Small Business Requests for a given fiscal year beginning August 1 of the prior year. Requests for the next fiscal year received before August 1 will not be accepted. Medical Device User Fee Small Business Qualification and Determination Guidance for Industry, Food and Drug Administration Staff and Foreign Governments July 2025 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-determination?utm_medium=email&utm_source=govdelivery

Now live: The 2026 Canadian Regulatory Compliance Handbook

https://academy.delltech.com/?error=Your%20order%20has%20timed%20out.%20Please%20try%20again. Now live: The 2026 Canadian Regulatory Compliance Handbook Dell Tech’s Canadian Regulatory Compliance Handbook is now available through Dell Tech Academy. This practical guide was created to help businesses better understand Canadian compliance requirements across key product categories, including Natural Health Products, cosmetics, foods, and more. It is designed to support clearer decision-making, smoother market access, and stronger regulatory preparedness.

Expert-led eLearning to Achieve Compliance & Improve Operations

https://www.registrarcorp.com/compliance-training/?utm_campaign=food-and-beverage-cosmetics-medical-device-drugs-registrar-newsfeed-07-28-2026&utm_medium=email&_hsenc=p2ANqtz-8bwlnyVTNyGSVgXdM4H7kHhCY-o9HL5R926VxnxJnmuOHvkmFZRlD3hGgSeqzvc5PWygs4frvt6V8k_8xu_jsRdbmUWA&_hsmi=430311558&utm_content=hyperlink&utm_source=hubspot Self-paced FDA Compliance Training Explore professional training courses covering Food Safety, Cosmetics, Pharmaceuticals, and Medical Device compliance topics, including PCQI, HACCP, FSVP, and MoCRA. Designed for regulatory professionals and industry teams, these courses help support compliance with FDA and global regulatory requirements through flexible, expert-led learning.

How Medical Device Companies Can Overcome EUDAMED 2026 Registration Challenges

https://www.registrarcorp.com/blog/medical-devices/medical-device-registration/eudamed-2026-registration/?utm_campaign=food-and-beverage-cosmetics-medical-device-drugs-registrar-newsfeed-07-28-2026&utm_medium=email&_hsenc=p2ANqtz-9Ka6icstFVPpNmPlp3Jq1s5dhQ6NO7iT2Vf0Uuw_fVqQp5ppBXWnTrLw46LX1nsxYzJNvmilBggLrpCAycsDOcpeFPDw&_hsmi=430311558&utm_content=medical-device-hyperlink&utm_source=hubspot EUDAMED 2026 Deadlines Will Impact EU Market Access EUDAMED is moving toward mandatory use, with key 2026 deadlines that will directly affect medical device and IVD manufacturers selling in the European Union. Companies must complete actor registration, device data submissions, and other required records to maintain compliance under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This article outlines the major deadlines and actions manufacturers should take now to avoid delays and maintain uninterrupted market access.

2026 FDA Food Facility Registration Renewal: What Food Exporters Need to Know

https://www.registrarcorp.com/blog/food-beverage/fda-renewal-2026-ffr-registration/?utm_campaign=food-and-beverage-cosmetics-medical-device-drugs-registrar-newsfeed-07-28-2026&utm_medium=email&_hsenc=p2ANqtz-_JxnVWw-IHkKA1HzU6GhsqnvPic1gC6U7VP-Q8NNHJlmCf737tBAPlTYuu3TlYaELcBjHv5_Ko-6zIuXYwlGKj3E_2VQ&_hsmi=430311558&utm_content=food-and-beverage-hyperlink&utm_source=hubspot FDA Food Facility Registration Renewal Opens for 2026 Food facility registration renewal is required every even-numbered year, and facilities that manufacture, process, pack, or hold food for U.S. consumption must submit their renewal between October 1 and December 31, 2026. Failure to renew can result in expired registration, shipment delays, product holds, and disruptions to U.S. market access. This article explains who must renew, key deadlines, and steps companies can take now to ensure compliance before the renewal period closes.

EU Fragrance Allergen Expansion: What the July 31, 2026 Deadline Means for Your Brand Jul 13, 2026

https://www.registrarcorp.com/blog/cosmetics/eu-fragrance-allergen-expansion-2026/?utm_campaign=food-and-beverage-cosmetics-medical-device-drugs-registrar-newsfeed-07-28-2026&utm_medium=email&_hsenc=p2ANqtz--5N1xr2Cmbgt1-bCAz5L5FGu7lqLSeZjYnKH1vICKDyOwLz45IAY4MJElYytnrEPmMYdhjMVFFUYa5QAKlOt8k3j08TA&_hsmi=430311558&utm_content=hyperlink&utm_source=hubspot EU Fragrance Allergen Deadline Arrives July 31 Beginning July 31, 2026, all new cosmetic products placed on the EU market must comply with expanded fragrance allergen labeling requirements under Regulation (EU) 2023/1545. The update increases mandatory allergen disclosures from 26 to approximately 82 substances and may require companies to update formulations, labels, Product Information Files (PIFs), Cosmetic Product Safety Reports (CPSRs), and CPNP notifications. Brands that fail to comply risk customs detentions, product recalls, and market withdrawal, making now the time to prepare for the deadline.

FDA Proposes Rule to Modernize Drug Manufacturing Registration Proposed rule would streamline registration for advanced distributed manufacturers and increase visibility into foreign drug supply sources

https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-modernize-drug-manufacturing-registration?utm_campaign=42504259-FnB%2C%20Cosmetics%2C%20Med%20Dev%2C%20Drugs%20%7C%20Newsfeed%20%7C%20Global%20%7C%202026&utm_medium=email&_hsenc=p2ANqtz-9v44-EMHC3g_teh9_yvvYv0yZj1qx3NhhAgxhl4tgyoQNO9bSE3KDBGPN1NymexqZaA8uC2MnP4FCSRHHtx6QztuCNdw&_hsmi=430311558&utm_content=429969268&utm_source=hs_email FDA has proposed a new rule that would streamline registration for distributed drug manufacturing facilities operating under a ""hub-and-spoke"" model while clarifying registration requirements for certain foreign drug manufacturers, including facilities that produce active pharmaceutical ingredients (APIs). If finalized, the rule would reduce administrative burden for innovative manufacturers while giving FDA greater visibility into global drug supply chains and upstream manufacturing activities by expanding applicability of listing requirements to more foreign drug manufactures who are not directly importing its produced products into the United States. Companies should review the proposal closely, as it signals FDA's continued focus on supply chain transparency, advanced manufacturing, and stronger oversight of foreign drug establishments.