Project Mercury
Hace 20 horas
domingo, 7 de diciembre de 2025
New Lancet series blends social science with medicine to tackle global health inequities
https://www.news-medical.net/news/20251205/New-Lancet-series-blends-social-science-with-medicine-to-tackle-global-health-inequities.aspx
Can doctors in California learn from a patient who was bounced from one specialist to another in Japan? Can clinicians in London take lessons from a patient seeking asylum while suffering a medical emergency at the U.S.-Mexico border? Can doctors treating refugees in Africa inform health policy around the world?
In RFK Jr.’s upside-down world of vaccines, panel votes to end hepatitis B shot at birth
https://www.news-medical.net/news/20251205/In-RFK-Jre28099s-upside-down-world-of-vaccines-panel-votes-to-end-hepatitis-B-shot-at-birth.aspx
Recent weeks have brought good news about vaccines, with studies indicating that flu vaccination reduces heart disease, shingles vaccines can prevent or slow dementia, and a single human papilloma virus shot protects a girl from cervical cancer for the rest of her life.
New Lancet case study series highlights how social forces shape patient health
https://www.news-medical.net/news/20251205/New-Lancet-case-study-series-highlights-how-social-forces-shape-patient-health.aspx
In November, The Lancet, one of the world's most esteemed medical journals, launched a new monthly series of case studies that goes beyond clinical diagnoses to illuminate the social and cultural forces that contribute to each patient's condition.
Billions still lack essential health services despite worldwide gains in coverage
https://www.news-medical.net/news/20251206/Billions-still-lack-essential-health-services-despite-worldwide-gains-in-coverage.aspx
Since 2000, most countries – across all income levels and regions – have made concurrent progress in expanding health service coverage and reducing the financial hardship associated with health costs, according to a new joint report from the World Health Organization (WHO) and the World Bank Group.
Cancer detection firm Freenome to go public via $330 million SPAC deal Company part of competitive race to spot disease early through blood-based tests
https://www.statnews.com/2025/12/05/freenome-plans-go-public-early-cancer-detection/
By Jonathan WosenDec. 5, 2025
West Coast Biotech & Life Sciences Reporter
RFK Jr.’s vaccine advisory panel is beset by incompetence, bias, and procedural chaos Its decisions will harm children and adults alike for years to come
https://www.statnews.com/2025/12/06/acip-vaccine-advisory-panel-incompetence-bias-expert/
By Dorit R. ReissDec. 6, 2025
Reiss is professor of law at UC Law San Francisco (formerly Hastings) who focuses on vaccine policy.
Hengrui, BeOne top new analysis of Chinese drug development The companies topped IDEA Pharma’s new China-focused Innovation and Invention Index
https://www.statnews.com/2025/12/07/jiangsu-hengrui-beone-chinese-biotech-innovation-ranking/
By Allison DeAngelisDec. 7, 2025
Biotech Startups and Venture Capital Reporter
RFK Jr.’s vaccine panel is laying the groundwork for more scrutiny of childhood shots Panel members overlooked evidence showing hepatitis B shots are safe and effective as they pulled back a recommendation
https://www.statnews.com/2025/12/05/cdc-acip-panel-entire-childhood-vaccine-schedule-under-scrutiny/
By Daniel Payne and Chelsea CirruzzoDec. 5, 2025
COP30: still failing to meet the challenge The Lancet Regional Health – Europe + +...
Editorial p1701 Health progress in a post-COVID-19 world The Lancet +++ +++ +
Global age-sex-specific all-cause mortality and life expectancy estimates for 204 countries and territories and 660 subnational locations, 1950–2023: a demographic analysis for the Global Burden of Disease Study 2023
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01330-3/fulltext?dgcid=hubsplot_email_lancet-gbdalerts_lancetgbdcap25&utm_campaign=gbdalerts&utm_medium=email&_hsenc=p2ANqtz--jkMUB51hdtZ7yh80sF21f3-B3vRpecK1HQP_axk1gaGafpxw6CLFKSPQZjCBBGIsLOY5MKcNfNuzPESnxSD2mCWw6fw&_hsmi=393166732&utm_content=393149489&utm_source=hs_email
Global, regional, and national burden of chronic kidney disease in adults, 1990–2023, and its attributable risk factors: a systematic analysis for the Global Burden of Disease Study 2023
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01853-7/fulltext?dgcid=hubsplot_email_lancet-gbdalerts_lancetgbdcap25&utm_campaign=gbdalerts&utm_medium=email&_hsenc=p2ANqtz-8rGsY4jGLFVU2BdLlWU9Q8glhqVSbShukXkRnjJaLfDW14VLkIsWl5fj5dnbSZ2PQBZO2zXK0u8pqSKFyB_MV8ex2oAg&_hsmi=393166732&utm_content=393149489&utm_source=hs_email
Global, regional, and national burden of headache disorders, 1990–2023: a systematic analysis for the Global Burden of Disease Study 2023
https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(25)00402-8/fulltext?dgcid=hubsplot_email_lancet-gbdalerts_lancetgbdcap25&utm_campaign=gbdalerts&utm_medium=email&_hsenc=p2ANqtz-_Yt5srY0_G6fGJvB_nBroN8yynkVog9mNlmjiim1OxI4VZO582PxzgspXsBKzj8WMEyX2oUwi2r5Jp6PTuWAxSCxrAmA&_hsmi=393166732&utm_content=393149489&utm_source=hs_email
Health progress in a post-COVID-19 world
The Lancet
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01947-6/fulltext?dgcid=hubspot_email_lancet-gbdalerts&utm_campaign=gbdalerts&utm_medium=email&_hsenc=p2ANqtz--irTkDVQMomlZqhvXj_js1KRmoK6KhgfVLSntceEWxev1amS81WJDXt-rMvcK_dFn9eP2WbN1ucWC-JZwTIjFYsSER0Q&_hsmi=393166732&utm_content=393149489&utm_source=hs_email
The burden of diseases, injuries, and risk factors by voivodship in Poland, 1990–2023: a systematic analysis for the Global Burden of Disease Study 2023
https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(25)00223-6/fulltext?dgcid=hubspot_email_lancet-gbdalerts_lancetgbdcap25&utm_campaign=gbdalerts&utm_medium=email&_hsenc=p2ANqtz--9MLBbea_mnVay_hmYK-evh_G4E7_qRz_5iJy3rYLXLaj8HP7Mj6HJhIOJNeO6JokrhJixxIMPOHIIYhfdKShDxOUz-g&_hsmi=393166732&utm_content=393149489&utm_source=hs_email
Leveraging socioeconomic development for maternal health, breast cancer, and gynaecological cancers across 204 locations: a stochastic frontier analysis from the Global Burden of Disease Study 2023
https://www.thelancet.com/journals/lanogw/article/PIIS3050-5038(25)00031-7/fulltext?dgcid=hubspot_email_lancet-gbdalerts_lancetgbdcap25&utm_campaign=gbdalerts&utm_medium=email&_hsenc=p2ANqtz-8L6UVn_fpPM8YiZLVMmQk8WYH9lJOM0pUdwNEC49hGIRcOCyHOR6133SOUFDgRFWtnsEuZ9dtfzBGxmS7_SCmeSowdcA&_hsmi=393166732&utm_content=393149489&utm_source=hs_email
Missing mortality: closing the data gaps
https://www.thelancet.com/journals/lancet/issue/vol406no10513/PIIS0140-6736(25)X0042-8
Inequalities and Disparities in Cardiovascular Health
https://www.thelancet.com/series-do/inequalities-disparities-cvd?dgcid=hubspot_email_conferencealerts_lanepecardiohealth25&utm_campaign=conferencealerts&utm_medium=email&_hsenc=p2ANqtz--JxGxR0yPp7AeEcM1uwaIzBIdMxSN-gazSLbsWY6qrL2xrAb_A6R2Me8qO1CvV_K-9du8lDdSOwwh5hytqHj7Ga5PZ3w&_hsmi=391400172&utm_content=391400172&utm_source=hs_email
Despite well-established health-care systems in many high-income and middle-income regions, persistent gaps in representation, access, and care continue to undermine equity in cardiovascular health, resulting in disproportionate disease burden and disparities in outcomes. This Series examines the structural and systemic drivers of disparities affecting four populations at high risk: women, racial and ethnic minorities, older adults, and individuals with mental health conditions. Each paper in this Series synthesises current evidence and proposes actionable, evidence-based strategies to promote equity in the prevention, diagnosis, and management of cardiovascular diseases. Tackling these disparities requires an intersectional, inclusive, and patient-centred approach that addresses sex, race, age, mental health, and socioeconomic determinants across clinical and public health systems
sábado, 6 de diciembre de 2025
Very Few Parents Report Skipping or Delaying the Hepatitis B Vaccine for their Children +++++
Very Few Parents Report Skipping or Delaying the Hepatitis B Vaccine for their Children
Dec 5, 2025
https://www.kff.org/quick-take/very-few-parents-report-skipping-or-delaying-the-hepatitis-b-vaccine-for-their-children/
“Our recent [survey] found very few parents (9%) report skipping or delaying the hepatitis B vaccine for their children...this is similar to a 2023 KFF survey showing that most adults overall stayed up-to-date on the hepatitis B vaccine, with just 10% reporting having skipped or delayed it.”
Status of Abortion Litigation in State Courts
Dec 5, 2025
https://www.kff.org/womens-health-policy/status-of-abortion-litigation-in-state-courts/
This State and Federal Reproductive Rights Litigation tracker aggregates information about ongoing litigation regarding abortion bans and restrictions, FDA approval of Mifepristone (an abortion pill) and other federal regulations.
Litigation Involving Reproductive Health and Rights in the Federal Courts
Dec 5, 2025
https://www.kff.org/womens-health-policy/litigation-involving-reproductive-health-and-rights-in-the-federal-courts/
This State and Federal Reproductive Rights Litigation tracker aggregates information about ongoing litigation regarding abortion bans and restrictions, FDA approval of Mifepristone (an abortion pill) and other federal regulations.
Litigation Challenging the 2025 Budget Reconciliation Law’s Provision Blocking Federal Medicaid Payments to Planned Parenthood
Dec 5, 2025
https://www.kff.org/womens-health-policy/litigation-challenging-the-2025-budget-reconciliation-laws-provision-blocking-federal-medicaid-payments-to-planned-parenthood/
This brief provides an overview of these legal challenges and summarizes the key positions of the plaintiffs and the defendants, Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS).
KFF Health Tracking Poll: Knowledge and Views of Medication Abortion
Dec 5, 2025
https://www.kff.org/public-opinion/kff-health-tracking-poll-knowledge-and-views-of-medication-abortion/
This KFF Health Tracking Poll finds that many, including women of reproductive age, remain unfamiliar with key facts about mifepristone. Fewer than half of all adults say they believe abortion pills are safe now, compared to over half of all adults two years ago. This poll explores awareness and perception of the recent FDA review of the medication, and support for policies aimed at restricting it.
Longer Looks: Interesting Reads You Might Have Missed
https://kffhealthnews.org/morning-breakout/longer-looks-interesting-reads-you-might-have-missed-243/
Each week, KFF Health News finds longer stories for you to enjoy. Today's selections are on relationships, mental health, Parkinson's, rabies, and more.
New York Health System May See Cuts, Missed Payroll Without Urgent Aid
https://kffhealthnews.org/morning-breakout/new-york-health-system-may-see-cuts-missed-payroll-without-urgent-aid/
North Star Health Alliance in Ogdensburg, New York, is "facing imminent closure," according to CEO Richard Duvall. Plus, news from California, Florida, and Missouri.
Mark Cuban’s Cost Plus Drugs, Humana May Join Forces To Lower Drug Costs
https://kffhealthnews.org/morning-breakout/mark-cubans-cost-plus-drugs-humana-may-join-forces-to-lower-drug-costs/
The two are in talks to explore how they can lower prescription drug prices with a direct-to-employer model. Plus: A look at why turning human blood into medications is big business; CMS wants to encourage technology-supported care through wearable reimbursements; and more.
American Cancer Society OKs Self-Swab Screening For Cervical Cancer
https://kffhealthnews.org/morning-breakout/american-cancer-society-oks-self-swab-screening-for-cervical-cancer/
The updated recommendations were released Thursday and include new guidance on when women can stop being screened for cervical cancer. In other news, a new Texas law allows residents to sue those suspected of making, distributing, or mailing abortion pills in or out of the state.
Democrats Push For Vote On 3-Year Extension Of Enhanced ACA Subsidies
https://kffhealthnews.org/morning-breakout/democrats-push-for-vote-on-3-year-extension-of-enhanced-aca-subsidies/
A vote for a straightforward, three-year extension of the Affordable Care Act subsidies is expected in the Senate next week, Senate Democratic Leader Chuck Schumer announced Thursday. The GOP still has not settled on an alternate plan.
US-Kenya Health Pact Is First Of Likely Many Global Deals After USAID’s Exit
https://kffhealthnews.org/morning-breakout/us-kenya-health-pact-is-first-of-likely-many-global-deals-after-usaids-exit/
It's a five-year, $2.5 billion deal that focuses on preventing and treating diseases such as HIV/AIDS, malaria, and tuberculosis with an emphasis on faith-based medical providers, AP reported. Previously, there was a patchwork of health agreements run by the U.S. Agency for International Development before it was dismantled this year.
Vaccine Advisers Balk At Wording Of Proposed Hep B Guidance, Delay Vote
https://kffhealthnews.org/morning-breakout/vaccine-advisers-balk-at-wording-of-proposed-hep-b-guidance-delay-vote/
Advisory Committee on Immunization Practices panelists are taking a closer look at the recommendation, which was revised three times just before the meeting. They could vote today on whether newborns should get the shot. Plus, ACIP's trustworthiness is under the scope.
viernes, 5 de diciembre de 2025
Top Senate health leader calls CDC vaccine panel ‘totally discredited’ ACIP meeting this week includes presentation from anti-vaccine attorney
https://www.statnews.com/2025/12/04/cdc-vaccine-panel-senator-calls-acip-totally-discredited/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8o92CwfgV_buZJpbeuAncMj3WR-fYMgeU_kkoxY70QgX_xQ8BJVLYRYPRDPJs3B7_9YYWYST_-VVqT0EoLPpFj9q5VmA&_hsmi=393083194&utm_content=393083194&utm_source=hs_email
The first day of the latest Advisory Committee on Immunization Practices meeting was a doozy: a 30-year-old recommendation that all babies born in the U.S. be vaccinated at birth against hepatitis B seems likely to end.
Infectious diseases experts say the move could result in more than a thousand babies contracting the highly infectious virus each year, a chronic disease that can lead to premature death. The final vote was delayed until today, but yesterday’s discussion suggests that members are planning to overturn the existing policy with few dissenters (though it did get testy, thanks in part to pediatrician Cody Meissner).
It’s setting up to be a big win for health secretary Robert F. Kennedy Jr. and the anti-vaccine movement that supports him, even though hepatitis B shots have been given for decades and the current body of evidence indicates they are safe.
What else to expect for today? Presentations from two controversial figures: Tracy Beth Hoeg, the newly-named FDA drug center head, and Aaron Siri, Kennedy’s former personal attorney, who has represented people who have allegedly been harmed by vaccines. Senate health leader Bill Cassidy (R-La.) called the ACIP “totally discredited” on Thursday upon learning that Siri would be testifying.
FDA Memo Linking COVID Vaccines to Child Deaths May Boost Uncertainty Among Parents
https://www.kff.org/quick-take/fda-memo-linking-covid-vaccines-to-child-deaths-may-boost-uncertainty-among-parents/
When federal health officials frame unverified [Vaccine Adverse Event Reporting System] reports as evidence of vaccine-caused deaths, it may become more difficult for health communicators to explain the system’s limitations and the vaccines’ extensive safety evidence.
Morning Briefing: Today's News Summaries Thursday, Dec 4 2025 +++ +++ +
Morning Briefing: Today's News Summaries
Thursday, Dec 4 2025
Vaccine Committee Could Vote Today To End Newborn Hepatitis B Shots
The birth-dose recommendation has been in place since 1991. The Advisory Committee for Immunization Practices will meet again Friday to debate broader changes to the timing of vaccines given to children, as well as whether aluminum salts should be removed from vaccines, The New York Times reported. Plus, CIDRAP takes a deeper dive into the success of the newborn hep B shot.
https://kffhealthnews.org/morning-breakout/vaccine-committee-could-vote-today-to-end-newborn-hepatitis-b-shots/
FDA Is Reshuffling Leadership Roles As Angst Deepens With Pazdur Exit
Theresa Michele, the director of the Office of Nonprescription Drugs, has been reassigned. Tracy Beth Høeg will take the reins at the Center for Drug Evaluation and Research. Also, Richard Pazdur's abrupt retirement from CDER has reignited fears that the agency is imploding, Axios reports.
https://kffhealthnews.org/morning-breakout/fda-is-reshuffling-leadership-roles-as-angst-deepens-with-pazdur-exit/
At Wednesday Hearing, Senators Leave Door Open To Extending ACA Subsidies
No major overhaul seems possible before the end of the year, but optimism remained for an extension. Other news from Capitol Hill is on fraudulent Obamacare signups, President Donald Trump's role in any potential health care deal, health insurance affordability, and more.
https://kffhealthnews.org/morning-breakout/at-wednesday-hearing-senators-leave-door-open-to-extending-aca-subsidies/
Texas Bathroom Law Limits How Trans People Can Use Public Facilities
Senate Bill 8 restricts the kind of bathrooms in public spaces that are available to transgender people and holds institutions liable for violations of the law. Meanwhile, the University of Texas San Antonio is forcing students to change dorms to comply with the new law. Also in the news: California, North Carolina, Georgia, Minnesota, Missouri, and Ohio.
https://kffhealthnews.org/morning-breakout/texas-bathroom-law-limits-how-trans-people-can-use-public-facilities/
Mangione Back In Court Exactly 1 Year After United Healthcare CEO's Death
CEO Brian Thompson was gunned down Dec. 4, 2024, on a sidewalk outside a Manhattan hotel where UnitedHealth Group was holding its annual investors' meeting. In the year since, the case against shooting suspect Luigi Mangione, 27, has played out in pop culture in a way unlike anything in the modern media age, Baltimore Magazine writes.
https://kffhealthnews.org/morning-breakout/mangione-back-in-court-exactly-1-year-after-united-healthcare-ceos-death/
Court Ruling In India Shakes Up Global Market On Weight Loss Drugs
Indian drugmaker Dr. Reddy's Laboratories will be allowed to make a generic version of Novo Nordisk's semaglutide and export it even before some of Novo's global patents expire in 2026.
https://kffhealthnews.org/morning-breakout/court-ruling-in-india-shakes-up-global-market-on-weight-loss-drugs/
Viewpoints: Removing Designations Will Worsen Nursing Shortage; Overdiagnosis Debate Gets It Wrong
https://kffhealthnews.org/morning-breakout/viewpoints-removing-designations-will-worsen-nursing-shortage-overdiagnosis-debate-gets-it-wrong/
FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development
Upcoming Product-Specific Guidances for Generic Drug Product Development
https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-generic-drug-product-development
FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
Guidance for Industry
August 2024
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-specific-guidance-meetings-between-fda-and-anda-applicants-under-gdufa?utm_medium=email&utm_source=govdelivery
Today, FDA published a new batch of draft product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating evidence to support abbreviated new drug application (ANDA) approvals. FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to safe, effective, and high-quality treatments. Improving access to generic medicines supports the agency’s mission to advance public health, as outlined in our Drug Competition Action Plan, and accelerating the development and approval of generic drugs also advances the goals of the President’s Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First.
Today’s batch of 81 PSGs (44 New and 37 Revised) contains:
54 PSGs for products with no approved ANDAs (including 19 complex products)
28 PSGs for complex products (7 new and 21 revised PSGs)
PSGs for products used for treatment of resistant bacterial infections, cystic fibrosis, lung and thyroid cancer, seizures associated with Dravet syndrome, and other conditions
Additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs reference products used for first-in-class topical therapy for psoriasis patients and treatment of seborrheic dermatitis, wounds associated with dystrophic and junctional epidermolysis bullosa, and other conditions.
When finalized, the PSGs in today’s batch posting will describe the agency’s current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all comments to the public docket before finalizing PSGs.
Newly Updated – Upcoming PSGs
Tomorrow, FDA also will update the “Upcoming Product-Specific Guidances for Generic Drug Product Development” web page, which includes new and revised PSGs under development and includes the planned revision categories and brief descriptions of the revisions. As stated in the GDUFA III Commitment Letter, eligible applicants may request a PSG teleconference to obtain FDA’s feedback on the potential impact of a new or revised PSG on its development program and a subsequent PSG meeting following feedback received at the PSG teleconference. See the guidance for industry Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA for more information. The web page also provides information about the agency’s plans for issuing new or revised PSGs in the coming year for all generic drug products (complex and non-complex), along with anticipated publication dates, consistent with FDA’s GDUFA III commitments.
Noteworthy PSGs in Today’s Batch:
New PSG for treatment of seborrheic dermatitis; roflumilast topical foam (RLD: ZORYVE, NDA 217242)
New PSG for treatment of rare skin conditions, dystrophic epidermolysis bullosa and junctional epidermolysis bullosa; birch triterpenes topical gel (RLD: FILSUVEZ, NDA 215064)
Revised PSG to include a characterization-based BE approach for non-steroidal adjunct therapy for psoriasis; tapinarof topical cream (RLD: VTAMA, NDA 217806)
Revised PSGs for multiple modified-release drug products to remove in vitro alcohol dose dumping studies due to new GDUFA-funded research that suggests such studies are not needed: carbinoxamine maleate oral extended release suspension; (RLD: KARBINAL ER NDA 022556); carvedilol phosphate oral extended release capsule (RLD: COREG CR, NDA 022012); diltiazem hydrochloride oral extended release capsule (RLD: CARDIZEM CD, NDA 020062); posaconazole oral delayed release for suspension (RLD: NOXAFIL POWDERMIX KIT, NDA 214770); trospium chloride oral extended release capsule (RLD: SANCTURA XR, NDA 022103)
Revised PSGs for complex peptides to clarify recommendations on the conduct of in vitro innate immune response assays, and when recombinant generic peptides can be submitted through the generic pathway. These include calcitonin (RLD: CALCIMAR, NDA 017769); glucagon (RLD: BAQSIMI, GVOKE, NDA 210134, 212097); dasiglucagon (RLD: ZEGALOGUE, NDA 214231); pegcetacoplan (RLD: EMPAVELI, SYFOVRE, NDA 215014, 217171); tirzepatide (RLD: MOUNJARO, NDA 215866); teriparatide (RLD: FORTEO, NDA 021318); liraglutide (RLD: VICTOZA, SAXENDA, NDA 022341, 206321); semaglutide (RLD: WEGOVY, NDA 215256); vosoritide (RLD: VOXZOGO, NDA 214938).
FDA Drug Competition Action Plan
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan?utm_medium=email&utm_source=govdelivery
November 6, 2025: Digital Health Advisory Committee Meeting Announcement November 6, 2025
https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-2025-digital-health-advisory-committee-meeting-announcement-11062025?utm_medium=email&utm_source=govdelivery
Reminder: Submit Comments on Generative AI-enabled Digital Mental Health Medical Devices
The FDA’s Digital Health Advisory Committee met on November 6, 2025, to discuss the topic of generative artificial intelligence (AI)-enabled digital mental health medical devices. The public may submit written comments on this topic to docket number FDA-2025-N-2338 by December 8, 2025, for review and consideration by the FDA.
Quality and Regulatory Predictability: Shaping USP Standards December 11, 2025
https://www.fda.gov/drugs/news-events-human-drugs/quality-and-regulatory-predictability-shaping-usp-standards-12112025?utm_medium=email&utm_source=govdelivery
December 11, 2025 | 9:00 AM - 10:30 AM ET
By hosting this webinar, the Association for Accessible Medicines (AAM), FDA, and United States Pharmacopeia (USP) aim to increase stakeholder awareness of, and participation in, the USP standards development process, ultimately contributing to product quality and regulatory predictability throughout the drug development, approval, and product lifecycle.
Public quality standards are universally recognized as essential tools that support the design, manufacture, testing, and regulation of drug substances and products. USP standards play a critical role in helping ensure the quality and safety of medicines marketed in the United States and worldwide.
This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs. Attendees will gain insights into the USP standards development process and learn how they can sponsor or participate—via public comment—in the development of future standards.
SOPS Nursing Home Survey Version 2.0: Updates, Insights, and Implementation December 17, 2025 1:00 PM - 2:00 PM EST
https://cma.ahrq.gov/cma/welcome.jsp?code=sops_nursing_home_2_webinar
This one-hour webcast will introduce Version 2.0 of the Surveys on Patient Safety Culture® (SOPS®) Nursing Home Survey, highlighting key improvements--including a shortened and more focused survey--and results from a pilot test with 27 nursing homes. Speakers from AMI Expeditionary Healthcare will describe their first-hand experience using the new survey in a field test. Also, they will discuss how they achieved greater than 50 percent response rates in eight nursing homes in Pennsylvania and how they are reviewing the results and preparing action plans for the participating nursing homes.
Speakers:
Jonathan Bakdash, Ph.D., Social Science Analyst, Agency for Healthcare Research and Quality
Naomi Yount, Ph.D., Principal Research Associate, Westat
Jamie Thomas, M.S.N., M.B.A., R.N., Senior Quality Improvement Manager, AMI Expeditionary Healthcare
William Martyak, PA-C, Chief Clinical Officer, AMI Expeditionary Healthcare
Joann Sorra, Ph.D. (Moderator), Vice President, Westat
For questions, please contact the SOPS User Network at SafetyCultureSurveys@westat.com or call 1-888-324-9749.
jueves, 4 de diciembre de 2025
What West Virginia teens lost when CDC cuts ended their fight against Big Tobacco
What West Virginia teens lost when CDC cuts ended their fight against Big Tobacco
‘What am I going to do from here on out?’ one youth activist asks
By Sarah ToddDec. 4, 2025
BBreanna Cutright was getting her nails painted purple for junior prom when the email arrived on her phone with bad news. Raze, an anti-tobacco program focused on young people across West Virginia, was shutting down because of federal funding cuts.
https://www.statnews.com/2025/12/04/impact-cdc-cuts-tobacco-activist-story-american-science-shattered-series/
Tracking Implementation of the 2025 Reconciliation Law: Medicaid Work Requirements
https://www.kff.org/medicaid/medicaid-work-requirements-tracker-overview/
KFF's interactive tracks key data and policies that will affect how states implement Medicaid work requirements, which are required under the 2025 budget reconciliation law starting in January 2027. The tracker includes state-level data on Medicaid enrollment and renewal outcomes as well as current state enrollment and renewal policies.
Recent Changes in Children’s Vaccination Rates by Race and Ethnicity Authors: Latoya Hill, Nambi Ndugga, Samantha Artiga, Josh Michaud, and Jennifer Kates Published: Dec 3, 2025
https://www.kff.org/racial-equity-and-health-policy/recent-changes-in-childrens-vaccination-rates-by-race-and-ethnicity/
Data show that children’s vaccination rates, including MMR and seasonal flu vaccines, have declined in recent years largely due to decreases in vaccinations among White and Asian children. At the same time, and despite the declines among White and Asian children, Black and AIAN children remain least likely to have received recommended childhood vaccinations and the MMR vaccine specifically.
Racial Disparities in Maternal and Infant Health: Current Status and Key Issues Authors: Latoya Hill, Alisha Rao, Samantha Artiga, and Usha Ranji Published: Dec 3, 2025
https://www.kff.org/racial-equity-and-health-policy/racial-disparities-in-maternal-and-infant-health-current-status-and-key-issues/
This brief includes data on pregnancy and birth outcomes by race and ethnicity, describes the underlying factors driving disparities, and discusses current policies affecting maternal and infant health disparities.
2025 KFF Marketplace Enrollees Survey Authors: Lunna Lopes, Grace Sparks, Mardet Mulugeta, Isabelle Valdes, and Ashley Kirzinger Published: Dec 4, 2025
https://www.kff.org/public-opinion/2025-kff-marketplace-enrollees-survey/
This survey explores how ACA Marketplace enrollees expect to respond if their premium payments doubled as expected in 2026 when enhanced premium tax credits are set to expire. About a third would very likely look for a lower-cost plan, even if it had higher deductibles, and about a quarter would very likely end up uninsured. The survey also examines how increased health care costs may affect their finances and the potential impact in next year's elections.
Morning Briefing: Today's News Summaries Wednesday, Dec 3 2025 +++ +++ +
Morning Briefing: Today's News Summaries
Wednesday, Dec 3 2025
ACIP Appears Poised To Shake Up Childhood Immunization Schedule
https://kffhealthnews.org/morning-breakout/acip-appears-poised-to-shake-up-childhood-immunization-schedule/
The Advisory Committee on Immunization Practices this week is reconsidering whether hepatitis B shots should be given at birth and whether some combination vaccines should be given separately.
Pazdur Retiring From FDA Just 1 Month After Taking Job As Top Drug Regulator
https://kffhealthnews.org/morning-breakout/pazdur-retiring-from-fda-just-1-month-after-taking-job-as-top-drug-regulator/
Richard Pazdur was named director of the Center for Drug Evaluation and Research, or CDER, in November. He was the fourth person in the position this year and had been expected to help stabilize the agency. More administration news is on SNAP, Veterans Affairs, ICE activity, and more.
HHS Officially Repeals Biden-Era Nursing Home Staffing Mandate
https://kffhealthnews.org/morning-breakout/hhs-officially-repeals-biden-era-nursing-home-staffing-mandate/
Consumer groups expressed concern over the pullback. Other health care industry news is on physician burnout, AI scribes, pharmacy benefit managers, and more.
Hospital-At-Home Funding Extended Five Years Under House-Passed Bill
https://kffhealthnews.org/morning-breakout/hospital-at-home-funding-extended-five-years-under-house-passed-bill/
The measure has bipartisan support in the Senate and is expected to pass. Meanwhile, with the clock ticking down on Affordable Care Act subsidies, it doesn't appear Congress will find common ground and extend those tax credits to Americans insured through Obamacare.
Judge Lifts Ban On Planned Parenthood Medicaid Funding, With Caveat
https://kffhealthnews.org/morning-breakout/judge-lifts-ban-on-planned-parenthood-medicaid-funding-with-caveat/
The federal judge's new injunction would remove the onus on states to figure out which of their health care providers are covered by the ban and to stop funding the non-abortion services the clinics provide to Medicaid patients, Politico reports. The injunction is paused for seven days to allow the Justice Department to appeal to a higher court.
San Francisco Alleges 10 Big Companies Knew Harms Of Ultraprocessed Food
https://kffhealthnews.org/morning-breakout/san-francisco-alleges-10-big-companies-knew-harms-of-ultraprocessed-food/
The city's lawsuit names Kraft Heinz, Mondelez, Post, Coca-Cola, PepsiCo, General Mills, Nestle USA, Kellogg, Mars, and ConAgra Brands. Other news is on dementia, cancer, norovirus, and more.
Viewpoints: CDC’s Vaccine Advisory Panel Created A Crisis; FDA’s Leaked Covid Memo Exposes Reckless Risks
https://kffhealthnews.org/morning-breakout/viewpoints-cdcs-vaccine-advisory-panel-created-a-crisis-fdas-leaked-covid-memo-exposes-reckless-risks/
A sustainable primary care approach for obesity The Lancet Primary Care ++... ++
https://www.thelancet.com/journals/lanprc/article/PIIS3050-5143(25)00086-X/fulltext?dgcid=raven_jbs_etoc_email
Nov 2025
Volume 1Number 5
https://www.thelancet.com/journals/lanprc/issue/vol1no5/PIIS3050-5143(25)X0006-6
Integrating oral pre-exposure prophylaxis delivery in primary care family planning clinics: a pragmatic, stepped-wedge, cluster-randomised trial
https://www.thelancet.com/journals/lanprc/article/PIIS3050-5143(25)00057-3/fulltext?dgcid=raven_jbs_etoc_feature_lanprc
Targeted cardiovascular risk screening through an SMS programme (Text to Detect) in general practice: a three-arm, parallel group, randomised controlled trial
https://www.thelancet.com/journals/lanprc/article/PIIS3050-5143(25)00043-3/fulltext?dgcid=raven_jbs_etoc_feature_lanprc
2025 Chartbook for the CAHPS Child Hospital Survey Offers Insights Into Advancing Pediatric Quality and Safety +++...
https://www.ahrq.gov/sites/default/files/wysiwyg/cahps/cahps-database/2025-child-hcahps-infographic.pdf
Organizations that use the Surveys on Patient Safety Culture® (SOPS®) Hospital Survey can now access results from AHRQ’s 2025 Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Child Hospital Survey Database.
CAHPS Child Hospital Survey Database
https://www.ahrq.gov/cahps/cahps-database/child-hcahps-database/index.html
CAHPS (Child HCAHPS) Survey Chartbook is a valuable resource for understanding pediatric inpatient experience. The Child HCAHPS Survey asks parents or guardians to report on both their child’s inpatient experiences and their own experience with their child’s inpatient stay, including key aspects of care such as communication, responsiveness, and safety. These insights can help children’s hospitals and pediatric units strengthen their safety culture by integrating patient experience data into quality improvement efforts.
Results from the 2025 Child HCAHPS Survey Database include 8,392 responses voluntarily submitted by 39 hospitals. Survey data were collected from January through December 2024. Key highlights include the following:
High-scoring measures were Communication Between You and Your Child’s Doctors and Communication Between You and Your Child’s Nurses.
Low-scoring measures were Preventing Mistakes and Helping You Report Concerns and Quietness of the Hospital Room.
New in 2025:
The Child HCAHPS Survey Database added a correlation table (see graphic on right) displaying how each measure relates to the respondent’s rating of the hospital and willingness to recommend the hospital.
https://www.ahrq.gov/sites/default/files/wysiwyg/cahps/cahps-database/2025-child-hcahps-chartbook.pdf
Accelerating Rare disease Cures (ARC) Program
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/accelerating-rare-disease-cures-arc-program?utm_medium=email&utm_source=govdelivery
The U.S. Food and Drug Administration (FDA) has released the 2025 Accelerating Rare disease Cures (ARC) Program Annual Report.
Since its launch in 2022, the Center for Drug Evaluation and Research (CDER) ARC Program continues to be a key resource for the rare disease community and a driver of innovative approaches for rare disease drug development. The ARC Program is dedicated to driving scientific and regulatory innovation and engagement while closing the gap between the challenges of developing drugs for rare diseases and the urgent need for treatment options for patients.
Having built a strong foundation, the ARC Program is enthusiastic about the upcoming year as it continues to strengthen partnerships and empower innovation for rare disease drug development. CDER and the ARC Program maintain an unwavering commitment to improving outcomes and options for the rare disease community.
To learn more about the ARC Program, its accomplishments in 2025, and the future outlook of the program, please visit Accelerating Rare disease Cures (ARC) Program Annual Report: Resilience in Rare Disease Drug Development through Innovation and Partnerships.
Fostering the Future for American Children and Families 17 dic 2025 03:00 p. m.
https://www.whitehouse.gov/presidential-actions/2025/11/fostering-the-future-for-american-children-and-families/
The end of the year brings many of us together. Sometimes we gather as friends, and other times as worshippers. During this special time of year, our most cherished traditions are when we come together as family.
The HHS Faith Center is thinking about the role of family in all its iterations. Family is where we turn to for love, rest, growth, fun, and other similar reasons. While family is important to all of us, there are those in our communities who do not have safe and loving homes.
This is especially true for a number of youths in the foster care community. That’s why the President and First Lady unveiled the Fostering the Future for American Children and Families Executive Order in November.
Faith communities are meeting this need for foster families, and the White House is taking notice.
The inclusion of faith-based organizations in this Executive Order acknowledges the Trump Administration’s appreciation of faith groups stepping into the crisis for children in need. We invite you to join us on December 17th for our informative webinar on Fostering the Future (see more detailed information below).
The foundation of families is love. We all desire to give and receive love. Love informs our actions.
As we come together at this special time of the year, we celebrate those traditions that bond the family unit. It’s the love that we share that unifies us. The Christmas and Hanukkah season is a special time for families around the country to gather. The HHS Faith Center wishes you and yours a lovely Christmas, a joyful Hanukkah, and a prosperous New Year.
Please join the HHS Faith Center for a webinar titled 'Fostering and Faith: Partnerships to Serve Families' on Wednesday, December 17th, 2025 at 1:00PM ET on Zoom and hear how government seeks to partner with faith communities making a difference for foster youth in America. Register here to join us.
On November 13th, President Donald J. Trump and First Lady Melania Trump announced a new Executive Order, “Fostering the Future for American Children and Families”, to modernize America’s foster care system and empower young Americans transitioning out of foster care with greater tools, resources, and opportunities to promote lifelong independence and success.
Under Mrs. Trump’s leadership, this unprecedented presidential order unites Federal resources with innovative public- and private-sector partnerships, especially including partnerships with faith communities. The Order strengthens partnerships with faith-based organizations and houses of worship and directs action to stop discrimination based on religious beliefs, ensuring every qualified person is able to serve families and children in need.
The Trump Administration is ensuring our Nation’s foster care system harnesses the unparalleled generosity and resources available across our Nation to serve every child.
Join us to hear from key federal officials as well as faith and community leaders who are leading the charge to address the needs of foster youth in our community.
https://hhsgov.zoomgov.com/webinar/register/WN_IOrbjSa9S-awwgt_kQdaqQ#/registration
17 dic 2025 03:00 p. m.
Transforming liver care with artificial intelligence The Lancet Digital Health ++... +... +...
https://www.thelancet.com/journals/landig/article/PIIS2589-7500(25)00130-X/fulltext?dgcid=raven_jbs_etoc_email
Cancer, AI, and Health Equity
https://www.thelancet.com/series-do/cancer-ai-and-health-equity?dgcid=raven_jbs_etoc_feature_landigaicancer25
Oct 2025
Volume 7Number 10
https://www.thelancet.com/journals/landig/issue/vol7no10/PIIS2589-7500(25)X0010-8
“Investments in digital health should be balanced with the development of human expertise and necessary infrastructure to ensure timely, high-quality care for cancer patients.”
https://www.thelancet.com/journals/landig/home
miércoles, 3 de diciembre de 2025
AHRQ Safety Program for HAI Prevention
https://safetyprogram4hai-prevention.ahrq.gov/page/home
Register for Upcoming Webinars
AHRQ Safety Program for HAI Prevention: CAUTI Informational Webinar
December 11, 11:30 a.m.–12 p.m. ET
January 13, 3–3:30 p.m. ET
January 22, 2–2:30 p.m. ET
AHRQ’s Investments in Primary Care Research for 2023 and 2024
https://www.ahrq.gov/ncepcr/reports/2025-annual-report/index.html
In 2023 and 2024, AHRQ designated $84.1 million to new primary care research projects spanning fiscal years 2023–2029. These investments aim to strengthen primary care systems, improve patient outcomes, address health disparities, and advance innovations that benefit patients, clinicians, and communities. The agency’s second comprehensive review of recent primary care research investments is designed to inform and support primary care researchers, clinicians, and policymakers nationwide. It offers updates from AHRQ’s National Center for Excellence in Primary Care Research, a high-level analysis of the agency’s primary care research portfolio, and summaries of grants and resources across nine key topic areas. It also features impact stories and research profiles that spotlight projects with strong potential to improve primary care. Access the report to learn more.
Primary Care Practice-Based Research Networks Publications, 2014–2023: Synthesis Report
https://www.ahrq.gov/ncepcr/communities/pbrn/publications-synthesis-report.html
AHRQ has released a report from its National Center for Excellence in Primary Care Research (NCEPCR) that catalogues the past 10 years of Practice-Based Research Network (PBRN) publications. The Primary Care Practice-Based Research Networks and Publications, 2014–2023: Synthesis Report showcases the breadth and depth of PBRN research and demonstrates its value and impact. This work contributes to NCEPCR’s vision of a future where all patients receive high-quality, whole-person, evidence-based, affordable primary healthcare from a healthy primary care workforce. Accompanying the synthesis report is an Excel database containing the complete list of PBRN publications analyzed. This filterable, sortable resource can help researchers, clinicians, and PBRNs identify publications by topic, network, and other data points.
Allergy alerting and overrides for opioid analogues across two health systems
https://pubmed.ncbi.nlm.nih.gov/40414628/
An AHRQ-funded study in BMJ Health & Care Informatics found that 72 percent of opioid drug allergy alerts were overridden by clinicians. Researchers reviewed 700,493 opioid allergy alerts issued by clinical decision support systems across two major health systems in 2019. Of the overridden alerts, 74 percent involved low- or medium-severity reactions, while 29 percent were linked to true immune-related allergies—the types most likely to cause serious reactions like anaphylaxis. The findings suggest that many alerts may not reflect clinically significant risks. Furthermore, the high number of low-risk alerts may be causing alert fatigue, making it harder for clinicians to recognize and respond to serious warnings. The authors concluded that reclassifying alerts tied to low-risk, non-immune reactions—which represent up to 46 percent of currently interruptive alerts—could reduce unnecessary interruptions and help clinicians focus on truly critical warnings.
Resources and Tools on Patient and Healthcare Workforce Safety
Resources and Tools on Patient and Healthcare Workforce Safety: Resources and Tools on Patient and Healthcare Workforce Safety
AHRQ’s National Action Alliance for Patient and Workforce Safety (NAA) has released a new resource, the Best Practices To Strengthen Safety Culture, Leadership, and Governance Change Package. The NAA developed this package by identifying exemplar health systems in patient safety based on publicly available data, observing their practices on site, and engaging staff and leadership in dialogue to understand their approaches. In a September NAA webinar, leaders from Houston Methodist, Mayo Clinic, and St. Luke’s University Health Network discussed the key elements of the change package—safety culture, leadership, and governance—and how these principles are applied in daily practice. The panelists also answered questions on topics such as responding to safety events and communicating with staff. At St. Luke’s, for example, a patient safety officer investigates serious safety events in real time. “If it had a serious impact, we will convene the group within 48 hours and analyze the root cause,” said Donna Sabol, M.S.N., R.N., whose team also writes monthly thank-you notes to team members who report safety events. For further insights and candid discussion of how to address real-world safety challenges, explore the change package. Access the webinar recording.
Webinar: Safety Best Practices of High-Performing Healthcare Systems Related to Safety Culture, Leadership and Governance
https://www.ahrq.gov/action-alliance/webinars/safety-best-practices.html
NATIONAL ACTION
ALLIANCE FOR PATIENT
AND WORKFORCE SAFETY
https://www.nasa.gov/mission_pages/station/main/index.html
Emerging Best Practices for Addressing Suicidality in Primary Care
https://integrationacademy.ahrq.gov/products/topic-briefs/emerging-best-practices-addressing-suicidality-primary-care?c-10-ANN
The AHRQ Academy for Integrating Behavioral Health and Primary Care has introduced three new tools to advance behavioral health integration:
Behavioral Health Integration (BHI) Ecosystem Directory: An interactive, searchable directory of organizations—including federal agencies, academic centers, and nonprofits—that can help providers, policymakers, funders, researchers, and others find the right partners to support their organization’s behavioral health integration goals.
Updated Integrating Behavioral Health and Primary Care Playbook: Now redesigned for easier navigation, the Playbook features clearer guidance on financing and payment strategies, whole-person care, and community engagement. Access new content on electronic health record optimization, population health management, quality improvement, workforce solutions, and telehealth to enhance integration and reduce provider burnout.
Emerging Best Practices for Addressing Suicidality in Primary Care: The latest topic brief helps primary care teams identify and respond to suicide risk through practical, scalable interventions such as safety planning, crisis response, motivational interviewing, Caring Contacts, and integrating the 988 Suicide & Crisis Lifeline into routine care.
Behavioral Health Integration Ecosystem Directory
https://integrationacademy.ahrq.gov/bhi-directory?c-8-ANN
Integrating Behavioral Health and Primary Care Playbook
https://integrationacademy.ahrq.gov/products/playbooks/behavioral-health-and-primary-care?c-9-ANN
FDA and Triangle CERSI Announce Virtual Workshop on Pediatric Drug Development Safety and New Approach Methodologies
https://reg.learningstream.com/reg/event_page.aspx?ek=0087-0030-f8d67ef7bf954d1cad1374c8dc1bed56&utm_medium=email&utm_source=govdelivery
On December 5, 2025, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology, in collaboration with the Triangle Center of Excellence in Regulatory Science and Innovation (CERSI), will hold a virtual workshop entitled “Pediatric Developmental Safety Assessment: New Approach Methods”.
At this workshop, speakers and participants will: (1) gain an understanding of current programs in federal agencies related to novel alternative methods and pediatric developmental biology; (2) discuss the identification and utilization of secondary targets in a pediatric developmental safety assessment; (3) review the use of juvenile animal studies and in vitro tools to assess pediatric developmental safety assessment; and (4) explore the use of model-informed drug development techniques in pediatric developmental safety assessment.
More information about this event can be found at the Pediatric Developmental Safety Assessment: New Approach Methods web page.
https://www.fda.gov/drugs/news-events-human-drugs/pediatric-developmental-safety-assessment-new-approach-methods-12052025?utm_medium=email&utm_source=govdelivery
Prepping for the Future: Digital Solutions for Aging Populations Event Date: December 17, 2025 | 1:30pm – 3:00pm ET
https://digital.ahrq.gov/national-webinars/prepping-future-digital-solutions-aging-populations
AHRQ National Webinar on Prepping for the Future: Digital Solutions for Aging Populations
AHRQ will host a webinar on December 17th, 2025, from 1:30 – 3:00 p.m. ET that covers how digital technologies such as remote monitoring, telehealth, and personalized health apps are transforming care for older adults by enabling timely interventions, improving access, and supporting independence. Our expert panel will explore how these tools can improve health outcomes, overcome adoption barriers, and ensure older adults benefit from accessible, user-friendly, and effective digital solutions.
This webinar was previously scheduled for October. If you registered for that date, please re-register.
The panel includes:
Zhe He, Ph.D., FIAHSI, FAMIA
Professor, School of Information, Director, Institute for Successful Longevity, Florida State University
Valerie G. Press, M.D., M.P.H.
Professor of Medicine and Pediatrics, Associate Chief Clinical Transformation Officer, Medical Director, Care Transitions Clinic, University of Chicago
Jorie M. Butler, Ph.D.
Associate Professor, Biomedical Informatics and Geriatrics, Associate Director for Education and Evaluation, Salt Lake City VA, University of Utah
Moderator:
Kevin Chaney, M.G.S.
Senior Advisor for Dissemination and Innovation, Division of Digital Healthcare Research, Center for Evidence and Practice Improvement, AHRQ
What Japan is Doing to Encourage Drug Product Submissions: An Interview with MHLW’s Dr. Sato and PMDA’s Dr. Fujiwara
From a Global Perspective
By Daisaku Sato, M.D., and Yasuhiro Fujiwara, M.D
December 2, 2025
Japan, with a population of 125 million people, is the world’s fourth largest economy and the fourth largest pharmaceutical market in 2025. Its medical product regulators are considered among the top regulatory authorities worldwide. To better understand Japan’s approach to medical product regulation, the FDA’s Office of Global Policy and Strategy recently spoke with Dr. Daisaku Sato, Councilor for Pharmaceutical Affairs in Japan’s Ministry of Health, Labour and Welfare (MHLW) and Dr. Yasuhiro Fujiwara, Chief Executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the country’s regulatory counterpart to the FDA. The two men were in Washington, D.C., for meetings at the FDA and elsewhere.
Thank you for agreeing to speak with us. You, Dr. Fujiwara, are the Chief Executive of Japan's Pharmaceuticals and Medical Devices Agency, a position you’ve held since 2019. Could you explain how PMDA’s oversight of medical products differs from the FDA's?
Fujiwara: Thank you very much for having an opportunity to talk with the FDA. PMDA is Japan's regulatory authority for pharmaceutical and medical devices, serving as the direct counterpart to the FDA. We are an incorporated administrative agency, a governmental body operating under the jurisdiction of the Ministry of Health, Labour and Welfare. Last spring we marked our 20th anniversary, and as the third chief executive, I'm now in my seventh year in the role. What makes PMDA unique is that we are the world’s only public agency to integrate three core functions — application review, safety measures, and relief for adverse health injuries. In particular, our patient relief program for those suffering from adverse health effects associated with pharmaceuticals and related medical products is a distinct feature not found in other regulatory agencies.
Just like the FDA, we have both standard and some form of expedited review such as priority review for orphan products. A key difference from the FDA's review system is that in Japan, PMDA submits its review results to the Advisory Council in the Ministry of Health, Labour and Welfare, and the Minister of Health, Labour and Welfare grants marketing authorization for pharmaceuticals and medical devices based on the Advisory Council's opinion. Regarding our regulatory philosophy, we place a strong emphasis on a high degree of transparency and science-based assessment in all of our daily work. Moreover, PMDA is recognized as one of the world’s three leading regulatory authorities alongside the FDA and the European Medicines Agency. We are actively promoting international harmonization through ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] and IMDRF [International Medical Device Regulators Forum]. Given this perspective, I believe there are no fundamental differences in our relative philosophies between Japan and the United States.
You are here in Washington for the inaugural ceremony of PMDA's Washington, D.C., office. We understand this is the agency’s second foreign office. You opened your first in Bangkok, Thailand, last year in July. Could you explain why you've decided to open an office in Washington and what you hope to achieve by maintaining an office here?
Fujiwara: One of the key priorities of PMDA is to globalize our operations further. I strongly believe not just waiting in Japan — we must proactively go abroad and promote regulatory harmonization through direct dialogue with our international counterparts. In recent years, more and more overseas entities are leading the development of innovative pharmaceuticals and medical devices, particularly startups and venture companies in the United States. Thus, in Japan, it is necessary to help such companies develop pharmaceuticals and medical devices rapidly in Japan as well. It is also important for PMDA to provide such startups and other overseas companies with information on Japanese regulations, as well as our efforts toward the practical application of pharmaceuticals and medical devices to clinical practice.
To this end, PMDA has established a new office in Washington, D.C. The office serves as a point of contact for collaboration between Japanese and U.S. government agencies, including the FDA. Close collaboration is essential to advance regulatory harmonization and to facilitate the development of innovative products as well as enhance our review process and post market safety measures. Moreover, our D.C. office will provide general consultation services in English for U.S. startups and major companies who are interested in development in Japan. In this way the office aims to become a one-stop place for responding to Japanese pharmaceutical regulatory matters.
Furthermore, the staff of the D.C. office is not only participating in various academic conferences and events held in United States but also having direct contact and connection with the relevant academic organizations, enterprises, contract research organizations, etc. The staff will expand its network to clearly explain the Japanese regulatory system for pharmaceuticals and medical devices, introduce advantages in developing pharmaceuticals and medical devices in Japan, and intend to have an exchange of views with those relevant stakeholders. I hope that regulatory cooperation between Japan and the United States can be further enhanced through the D.C. office. By promoting access to innovative pharmaceuticals and medical devices that originate from the United States, I also contribute to PMDA’s purpose — making everyone's lives brighter together.
The U.K.-based nonprofit Center for Innovation and Regulatory Science (CIRS) issues an annual report on new drug approvals by six major regulatory authorities, the FDA, Health Canada, Swiss Medic, the Australian Therapeutic Goods Administration, the European Medicines Agency, and PMDA. The report focuses on median approval times. While this data can be a marker of agency performance and the time it takes to make medicines available to patients, other factors must be considered, the organization cautions.
In 2024, PMDA had the shortest median approval time for new drug approvals of the six regulatory authorities — 290 days —according to CIRS, followed by the FDA with 356 days. PMDA also achieved the shortest median approval time for orphan drugs of the six authorities. To clarify, these numbers take into account Japan's two-step drug approval process that begins with PMDA’s review of the submission followed by MHLW approval that you've explained already. I’d like to ask both of you to discuss this data. Let’s begin with you, Dr. Fujiwara.
Fujiwara: One of PMDA’s principles is, we’ll be the bridge between the patients and their wishes for faster access to safer and more effective pharmaceuticals and medical devices. In the past, reviews in Japan took longer, and that was criticized as a reason for delays in approval in Japan. Because of this, we increased the number of reviewers and made efforts to improve review abilities and efficiencies. PMDA began in 2004 with just about 250 staff, but we have grown into an organization of more than 1,000 experts. In addition, we offered consultations for various stages in the development period so that we can communicate with developers earlier in development. Such communication includes agreements on non-clinical data necessary for approval application and clinical trial designs. I think that those efforts resulted in smooth reviews and consequently, our review times became shorter.
Sato: My name is Daisaku Sato, Councilor for Pharmaceutical Affairs in the Ministry of Health, Labour and Welfare. I'm responsible for the pharmaceutical program at the Ministry. Thank you very much today for the opportunity to speak here. MHLW supervises the legal framework for the approval, manufacturing and marketing of medical products, and compliance activities involving manufacturers and marketing authorization holders. At the same time MHLW gives financial and operational support to PMDA's review process.
As mentioned by Dr. Fujiwara, in the process of approval of medical products, PMDA submits its review results to the Minister of Health, Labour and Welfare via its Advisory Council, and the Minister grants authorizations for pharmaceuticals and medical devices based on the Advisory Council's opinion. And while MHLW has the authority to make administrative decisions, it operates the review process efficiently in an integrated manner with PMDA in terms of management and coordination. We keep close communication with PMDA and the applicant company in a timely manner. For example, we convene advisory councils 20 times a year to ensure that the new products arrive to the public without delay.
Looking again at this report, while PMDA’s approval times are shorter than its five other regulatory counterparts, there is a substantial submission gap, that is, the period of when a company submits their first application to one of the six regulatory authorities, typically the FDA, before they submit that application to PMDA. In 2024, the submission gap was 1,427 days. Could you discuss this trend and what you're trying to do to bridge the gap?
Fujiwara: I see that one of the reasons for the delay in application submissions in Japan is that there is a delay in timing on the overseas company’s side to decide whether to develop in Japan. I think that is because those companies do not have information related to Japanese regulations and the Japanese market, or they do not understand the information correctly. In addition, since the development of many orphan and pediatric drugs are delayed in Japan, I think we need to provide support for the development of those drugs. As I mentioned before regarding the D.C. office, we currently provide general consultation services there and an outreach information program to academic conferences and events in the United States. We proactively carry out activities outside Japan, aiming to promote understanding of the Japanese regulatory system.
Furthermore, last year PMDA established a Center for Regulatory Consultation of Pediatric and Orphan Drugs and through consultation at this center, we support the development of orphan drugs and drugs for pediatric usage.
Sato: I will add some words from the policy perspective on drug regulations. The Japanese government is pursuing a policy to accelerate patient access to innovative medicines for unmet medical needs through facilitating research and development proactively in Japan as well as through regulatory reform so as to catch up to the drug product gap and loss between the U.S. and Japan. We keep a patient-centric approach to ensure treatment access not only in Japan but also in other regions, including the United States.
We have been responding to the internationally harmonized Good Clinical Practice (GCP) revisions and working to improve the clinical trial environment in Japan, in an internationally harmonized way, to facilitate implementation of multiregional clinical trials in Japan. I hope it will contribute to facilitating expedited global development of new medicines for wider patient populations overseas and it helps to make Americans healthy in the long run.
Further, we have removed the regulatory barriers in terms of the Japanese clinical data for initiating enrollment of Japanese patients in multiregional clinical trials. We have notified that domestic Phase I studies were not required in principle. We hope that this will enhance the predictability of development in Japan.
In addition, we have clarified two requirements: one is the designation criteria for orphan drugs, and the other is the requirement of additional Japanese data when confirmatory trials were conducted overseas. We have improved the environment to make it easier for Japanese submission as well as global development.
Most of those reforms that you're citing have happened in the last few years, is that correct?
Sato: Yes, in the last few years.
Could you share a few of your most notable collaborations with the FDA?
Fujiwara: Japan-U.S. cooperation is multilayered, ranging from collaboration in multilateral frameworks to bilateral partnership. Since the inception of ICH in 1990, Japan and the United States have been participating in discussions on the international harmonization of pharmaceutical regulations and leading its activities together, as founding regulators. Both countries have been playing major roles for many years as a chair and vice chair of the ICH Management Committee. Moreover, in the medical devices area, both of us have been leading discussions on global regulatory harmonization in the IMDRF. In 2024, the U.S. was the chair of the IMDRF and this year, in 2025, Japan took on the role of the chair. In addition, both Japan and United States are participating in various clusters such as the oncology area, pharmacovigilance, ATMP [advanced therapy medicinal products], and GCP to share information and exchange views regularly. There are confidential commitments between Japan and United States to cooperate closely with each other. Both countries exchange in confidence the information related to consultation, reviews, and safety measures.
Specifically, in the area of medical devices, through the initiative called harmonization by doing or “HBD” — industries, governments, and academia in both countries are working in tandem to promote regulatory harmonization on medical devices, focusing on clinical trials and review practices. This initiative resulted in various accomplishments such as solutions to challenges in multiregional clinical trials and its promotion, harmonization in data registries, and development of evaluation guidance. In such a way, both Japan and the United States have been collaborating closely as well as leading global regulatory harmonizations.
As a follow-up, tell us something about how you regulate medical devices. Is there considerable similarity between how you regulate devices and how FDA regulates devices?
Fujiwara: Very similar.
Sato: But we have a third-party notification system as well. And one thing I have to add is that we have had a collaboration with the FDA for the last 10 years in the PIC/S [Pharmaceutical Inspection Co-operation Scheme] framework for inspections.
We’d like to close by asking what you see as the future of the PMDA-FDA relationship?
Fujiwara: I recognize Japan and the United States have shared objectives and strategies in the regulatory area — that is to promote patient-centric health care, fully leverage scientific and technical process, and swiftly provide safer and more effective treatments. To achieve these objectives, I consider the following approaches, which are also common to Japan and the United States: First to ensure safety and efficacy of drugs, second, modernize reviews and safety monitoring with the use of big data and AI, third, accelerate access to innovative treatment, and finally, rebuild transparency and public trust. Specifically, those approaches include elements such as the use of real-world evidence, real-world data, initiatives to reduce animal testing and regulatory response to the development of pharmaceuticals for rare disease and pediatric disease. PMDA intends to continue Japan-U.S. cooperation through bilateral or multilateral collaborations, achieving such shared objectives and strategies, and contribute to the enhancement of public health in both countries and around the world.
Dr. Daisaku Sato is the Councilor for Pharmaceutical Affairs in Japan’s Ministry of Health, Labour and Welfare and Dr. Yasuhiro Fujiwara is the Chief Executive of Japan’s Pharmaceuticals and Medical Devices Agency, the country’s regulatory counterpart to the FDA.
FDA Grand Rounds – Advancing Real-World Evidence in FDA Regulatory Decision Making Thursday, December 11, 2025 12:00 p.m. - 1:00 p.m. ET
https://www.fda.gov/science-research/about-science-research-fda/fda-grand-rounds?utm_medium=email&utm_source=govdelivery
Title: FDA Grand Rounds: Advancing Real-World Evidence in FDA Regulatory Decision Making (CE credit offered)
Date: Thursday, December 11, 2025
Time: 12:00 pm - 1:00 pm ET
Via webcast
About the Speaker:
Marie Bradley, PhD
Senior Advisor for Real-World Evidence
Office of Medical Policy
Center for Drug Evaluation and Research
Dr. Marie Bradley is a Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). Her responsibilities related to real-world evidence (RWE) include serving as lead for the Advancing Real-World Evidence Program, the Real-World Evidence Subcommittee, and a portfolio of RWE demonstration projects. She also evaluates complex RWE-related study protocols submitted to the FDA. Recently, she has been helping to drive Agency level RWE initiatives in the Office of the Commissioner. Dr. Bradley is an established advocate, speaker, and panelist across national and international platforms on RWE-related topics and participates extensively in external engagement. She is a pharmacoepidemiologist and a pharmacist with over 16 years of experience working in regulatory, government, and academic sectors in the U.S. and the UK, including 11 years at the FDA. Dr. Bradley has a doctorate in pharmacoepidemiology and a master’s in pharmacy from Queen’s University Belfast, as well as a Master of Science in public health degree from London School of Hygiene and Tropical Medicine.
About the Presentation:
This presentation will explore how the FDA is using real-world data (data routinely collected in clinical practice) to generate real-world evidence (RWE) to inform regulatory decisions about the effectiveness and safety of medical products. The lecture will cover the evolution of this approach, highlight key activities of the FDA's Real-World Evidence program, and showcase selected guidance documents and demonstration projects that are advancing how we evaluate medical products.
CE credit will be offered. For more event information and to register:
https://www.fda.gov/grandrounds
https://www.fda.gov/science-research/about-science-research-fda/fda-grand-rounds?utm_medium=email&utm_source=govdelivery
martes, 2 de diciembre de 2025
SOPS Medical Office Survey: Webcast Now Posted— Patient Safety in Medical Offices: Using SOPS Tools to Drive Improvement
https://www.ahrq.gov/sops/surveys/medical-office/index.html
Webcast Now Posted—Patient Safety in Medical Offices: Using SOPS Tools to Drive Improvement
This webcast highlighted how the University of Georgia Health Center used AHRQ’s Surveys on Patient Safety Culture® (SOPS®) Medical Office Survey and resources to implement and track progress on improvement initiatives such as increasing workflow efficiency, enhancing teamwork, and empowering staff to voice safety concerns.
Speakers:
Jonathan Bakdash, Ph.D., Social Science Analyst, Agency for Healthcare Research and Quality
Amelia Ross, B.A., Manager of Quality and Health Equity, University of Georgia Health Center
Rose Tyler, M.S., Lead Research Associate, Westat
Lisa Huddleston, Ph.D., (Moderator), Senior Research Associate, Westat
Access a recording of the webcast and presentation slides.
https://www.ahrq.gov/sops/events/webinars/using-sops-tools-090925.html
For questions, please contact the SOPS User Network at SafetyCultureSurveys@westat.com or call 1-888-324-9749.
State Variations in the Role of the Reproductive Health Safety Net for Contraceptive Care Among Medicaid Enrollees Authors: Brittni Frederiksen and Alina Salganicoff Published: Dec 1, 2025
https://www.kff.org/womens-health-policy/state-variations-in-the-role-of-the-reproductive-health-safety-net-for-contraceptive-care-among-medicaid-enrollees/
This KFF analysis uses 2023 T-MSIS Research Identifiable Files to look at where reproductive-age female Medicaid enrollees received their last contraceptive visit by state. Overall, more than four in 10 (43%) female Medicaid enrollees received their last contraceptive visit of 2023 at a safety net provider, which includes Planned Parenthood clinics, community health centers, state and local health departments, and Indian health services, but there is wide variation by state.
5 Key Facts About Medicaid and Provider Taxes Authors: Alice Burns, Elizabeth Williams, Anna Mudumala, Elizabeth Hinton, and Robin Rudowitz Published: Dec 1, 2025
https://www.kff.org/medicaid/5-key-facts-about-medicaid-and-provider-taxes/
This issue brief uses data from KFF’s 2025-2026 survey of Medicaid directors to describe states’ current provider taxes, explore how the 2025 reconciliation law changed the federal rules governing provider taxes, and summarize potential impacts of the changes across states.
KFF Tracker: U.S. Pledges to Upcoming Multilateral Health Replenishments Published: Dec 1, 2025
https://www.kff.org/global-health-policy/kff-tracker-u-s-pledges-to-upcoming-multilateral-health-replenishments/
This KFF tracker provides up to date information on U.S. pledges thus far to four multilateral health replenishments (the Pandemic Fund, WHO, Gavi, and the Global Fund) and U.S. government support to date.
Global COVID-19 Tracker Published: Dec 1, 2025
https://www.kff.org/covid-19/global-covid-19-tracker/
This tracker provides data on global COVID-19 cases and deaths by country, region, and income-level. Additionally, the tracker reports current closure, economic, and health system policy responses to the COVID-19 pandemic globally. This tracker will be updated as new data are available.
Feds Promised ‘Radical Transparency’ but Are Withholding Rural Health Fund Applications By Sarah Jane Tribble and Arielle Zionts December 2, 2025
Feds Promised ‘Radical Transparency’ but Are Withholding Rural Health Fund Applications
KFF Health News filed records requests for states’ complete applications. Some have refused to release any of their materials.
https://kffhealthnews.org/news/article/rural-health-transformation-program-cms-state-applications-transparency/
Supreme Court To Review Case On Disclosure Of Anti-Abortion Donors
https://kffhealthnews.org/morning-breakout/supreme-court-to-review-case-on-disclosure-of-anti-abortion-donors/
In 2023, New Jersey's attorney general subpoenaed the names of donors to First Choice Women’s Resource Centers as part of an investigation into whether the organization was misrepresenting itself. Today, the Supreme Court will hear arguments in the case.
CMS To End Medicare Experiment Meant To Fix Kidney Dialysis Shortage
https://kffhealthnews.org/morning-breakout/cms-to-end-medicare-experiment-meant-to-fix-kidney-dialysis-shortage/
The trial, which will end Dec. 31, studied whether giving financial incentives to providers would move more patients with end-stage kidney disease onto home dialysis and through the transplant process, Stat reports. That approach was not proven to work.
US Opts Out Of World AIDS Day, Frustrating Activists On The Front Line
https://kffhealthnews.org/morning-breakout/us-opts-out-of-world-aids-day-frustrating-activists-on-the-front-line/
Other countries marked the day with public health declarations and commemorative ceremonies, while the Trump administration stayed silent about the epidemic. "I think it's emblematic of an administration that doesn't seem to care," one activist said.
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