viernes, 26 de diciembre de 2025
Why AI is a game-changer for faster, more targeted influenza vaccines
https://www.news-medical.net/whitepaper/20251223/Why-AI-is-a-game-changer-for-faster-more-targeted-influenza-vaccines.aspx
Influenza is responsible for a substantial amount of global illness and death every year. According to the World Health Organization (WHO), in February 2025, there were 3–5 million severe cases and 290,000 to 650,000 respiratory deaths worldwide resulting from seasonal flu epidemics.1
jueves, 25 de diciembre de 2025
Trump administration’s plan to shrink vaccine schedule sends health sector scrambling Hospitals and public health experts are uncertain how to address what would be a strikingly unusual change to U.S. vaccine policy
https://www.statnews.com/2025/12/23/trump-rfk-vaccine-schedule-healthcare-sector-considers-response/
By Daniel Payne, Chelsea Cirruzzo, and Helen BranswellDec. 23, 2025
How testosterone fell out of favor in medicine — and how it came back
Q&A with the doctor who pioneered modern testosterone treatment in America
https://www.statnews.com/2025/12/23/how-testosterone-treatment-was-rehabilitated-abraham-morgentaler-mens-health/
By Annalisa MerelliDec. 23, 2025
Contributing Writer
4 questions to understand the costs of ‘medical freedom’
Before policymakers change vaccine requirements, they need to ask these questions
https://www.statnews.com/2025/12/23/vaccine-policy-versus-medical-freedom-movement-4-questions/
How the Trump administration is recasting government’s role in regulating health technology
Agencies that used to set up and enforce guardrails now want to drive adoption of new, risky technologies
https://www.statnews.com/2025/12/23/trump-health-tech-ai-regulation/
By Casey Ross, Mario Aguilar, Katie Palmer, and Brittany TrangDec. 23, 2025
Rolling back health AI transparency rule will shift the burden of vetting to health systems The rule required disclosures around how clinical AI tools were developed and tested
https://www.statnews.com/2025/12/23/deregulating-health-ai-transparency-rule-shifts-burden/
By Casey RossDec. 23, 2025
Chief Investigative Reporter, Data & Technology
Major pharma companies may avoid Medicare experiments’ forced price cuts Some drugmakers that struck individual deals with Trump say they’re exempt from the Medicare effort
https://www.statnews.com/2025/12/23/trump-drug-pricing-deals-medicare-most-favored-nation-demos/
By John Wilkerson and Elaine ChenDec. 23, 2025
Proposed HHS rule on gender-affirming care radically expands use of Medicare, Medicaid as policy weapons If enacted, the rule will set a dangerous precedent
https://www.statnews.com/2025/12/24/gender-affirming-care-hhs-rule-medicare-medicaid-weapons/
By Carmel Shachar and Nicole HuberfeldDec. 24, 2025
Shachar is an assistant clinical professor of law at Harvard Law School. Huberfeld is Edward R. Utley professor of health law at Boston University School of Law & School of Public Health.
What giving flu shots backstage taught me about public health The performing arts world understands something increasingly disappearing from American life
https://www.statnews.com/2025/12/24/flu-shots-backstage-broadway-public-health/
By Ram KoppakaDec. 24, 2025
Koppaka is a public health physician and former senior CDC leader.
A Dose Of Upbeat And Inspiring News
A Dose Of Upbeat And Inspiring News
https://kffhealthnews.org/morning-breakout/a-dose-of-upbeat-and-inspiring-news-15/
Today's stories are about a paraplegic's trip to space, notable health care wins of 2025, philanthropy after loss, and a secret Santa's mission to boost the spirits of people in need.
ByHeart Formula Botulism Lawsuit Adds Target, Walmart, Whole Foods
ByHeart Formula Botulism Lawsuit Adds Target, Walmart, Whole Foods
The lawsuit has been brought against the infant formula maker on behalf of families whose babies were hospitalized with botulism. The plan to add the grocery store chains where the formula was sold to the lawsuits was announced on Sunday.
https://kffhealthnews.org/morning-breakout/byheart-formula-botulism-lawsuit-adds-target-walmart-whole-foods/
Nurses At 12 NYC Hospitals Prepared To Strike In New Year
Nurses At 12 NYC Hospitals Prepared To Strike In New Year
An end-of-year deadline sets up a potential work stoppage for about 20,000 nurses working at private hospitals in New York City. Other state health news is reported from North Carolina, Maine, Indiana, Illinois, Montana, and elsewhere.
https://kffhealthnews.org/morning-breakout/nurses-at-12-nyc-hospitals-prepared-to-strike-in-new-year/
New ALS Drug Targets Cell Mutation, May Slow Progression: Study
New ALS Drug Targets Cell Mutation, May Slow Progression: Study
The small study suggests that the drug, tofersen, might even be able to slow muscle degeneration and reverse ALS symptoms by targeting a specific mutation — SOD1 mRNA — which affects 2% of people with ALS. Plus: HIV drugs, a Nipah virus vaccine, hydroxychloroquine, and more.
https://kffhealthnews.org/morning-breakout/new-als-drug-targets-cell-mutation-may-slow-progression-study/
Aetna Adds IVF Coverage For Same-Sex Couples After Settlement
Aetna Adds IVF Coverage For Same-Sex Couples After Settlement
U.S. District Judge Haywood Gilliam, Jr. approved the agreement. Aetna will now cover IVF treatment for same-sex couples in the same way as heterosexual couples. This policy change will be applied nationally, and will benefit an estimated 2.8 million members.
https://kffhealthnews.org/morning-breakout/aetna-adds-ivf-coverage-for-same-sex-couples-after-settlement/
CMS Generates 400 Medicare-Funded Residency Slots
CMS Generates 400 Medicare-Funded Residency Slots
MedPage Today reports that the slots will be spread across 135 hospitals in 37 states, with almost two-thirds of them in primary care and psychiatry residency programs. Other health industry news is on medtech, CVS Health, outpatient cosmetic surgery, and more.
https://kffhealthnews.org/morning-breakout/cms-generates-400-medicare-funded-residency-slots/
Novo Nordisk’s Wegovy Becomes First GLP-1 Oral Pill After FDA Approval
Novo Nordisk’s Wegovy Becomes First GLP-1 Oral Pill After FDA Approval
The Wegovy pill has also been approved for reducing cardiovascular risks. Novo plans to launch the drug in January. Also in the news: the U.S. strikes health funding deals with nine African countries; Trump wants fewer guardrails on AI in health; and more.
https://kffhealthnews.org/morning-breakout/novo-nordisks-wegovy-becomes-first-glp-1-oral-pill-after-fda-approval/
miércoles, 24 de diciembre de 2025
February 10, 2026: Roundtable on Premarket Tobacco Product Application (PMTA) Submissions for Electronic Nicotine Delivery Systems (ENDS) Products February 10, 2026
https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-product-application-pmta-submissions-electronic?utm_campaign=ctp-pmta&utm_content=event&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms
FDA Announces Roundtable Discussion with Small ENDS Manufacturers on Premarket Application Submissions
FDA has issued a Federal Register notice (FRN) announcing a roundtable discussion with small tobacco product manufacturers (fewer than 350 employees) on February 10, 2026, 9 am–5 pm ET. The discussion aims to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products.
Viewing the meeting is open to the public, however roundtable participants are limited to 30 individuals representing manufacturers who have previously submitted an ENDS PMTA, including those with a PMTA currently pending with FDA.
FDA is hosting this roundtable to provide small ENDS manufacturers an opportunity to share their experience with, and other opinions about, the premarket application process. The topics to be discussed will include certain components of ENDS PMTAs such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk).
To register for the roundtable as a panelist, please do so at the event page by January 27, 2026, 11:59 p.m. Eastern Time. Registration for panelists is on a rolling basis and is determined by space availability, with priority given to early registrants. FDA will evaluate registrations based on the submitted information until a maximum of 30 participants have been selected for the roundtable. Due to time and space constraints, there is a limit of one person to represent and speak on behalf of each company. Participants should be at a sufficiently senior level with significant scientific and/or regulatory responsibility to be knowledgeable about their company’s PMTA. Panel registrants will receive confirmation as to whether they have been selected. If panelist registration closes prior to the submission deadline, we will update the website to reflect that change.
For non-panelists and members of the public interested in viewing the roundtable virtually, information will be provided on CTP’s website. The meeting will be captioned and recorded. Please visit the event page to learn more about attending the roundtable.
AHRQ Stats: Insurance Coverage for Heart Disease Treatment
https://meps.ahrq.gov/data_stats/Pub_ProdResults_Details.jsp?pt=Statistical+Brief&opt=1&id=1316
AHRQ Stats: Insurance Coverage for Heart Disease Treatment
Medicare paid for 57.6 percent of heart disease treatment costs in 2022, the most of any insurance type. Private insurance was the second most common coverage source, accounting for 24.2 percent of costs. (Source: AHRQ Medical Expenditure Panel Survey Statistical Brief #562, Healthcare Expenditures for Heart Disease among Adults Aged 18 and Older in the U.S. Civilian Noninstitutionalized Population, 2022.)
Join AHRQ EPC Grand Rounds session Jan. 20 on Workplace Safety and Well-Being
https://effectivehealthcare.ahrq.gov/news/jan-2026-grand-rounds
January 20, 1–3 p.m. ET: AHRQ Evidence-based Practice Center Program Grand Rounds session on Workplace Safety and Well-Being
AHRQ Safety Program for HAI Prevention
https://safetyprogram4hai-prevention.ahrq.gov/page/home
AHRQ Safety Program for HAI Prevention: CAUTI Informational Webinar
January 13, 3–3:30 p.m. ET
January 22, 2–2:30 p.m. ET
Study Finds Over-the-Counter Hearing Aid Safe but Challenging to Set Up
An over-the-counter hearing aid for adults with mild to moderate hearing loss is safe but could be difficult for users to set up, according to an AHRQ-funded study. Published in JMIR Human Factors. The study tested the hearing aid with 41 adults to see how easy and safe it was to use before release to the general public. Researchers also tested whether people who should not use the device, such as those with severe hearing loss or tinnitus, could recognize whether it was appropriate for them to use. Common problems among users included pairing the hearing aids with a phone and being able to tell the right and left earbuds apart. Researchers recommended clearer instructions, larger print, and more visible warnings on the box and in the app to help consumers use the device correctly and safely. The manufacturer addressed most of the identified issues prior to commercial release, demonstrating the benefit of rigorous human factors evaluation of over-the-counter medical devices.
https://pubmed.ncbi.nlm.nih.gov/39834141/
Targeted Interventions Improve Imaging Recommendations and Diagnostic Safety
An AHRQ-funded study in Radiology found that specific interventions reduced recommendations for additional imaging by 44 percent and made the remaining recommendations 7.6 times more actionable. About 10 percent of radiology exams include recommendations for additional imaging, which are meant to help clarify diagnoses but may contribute to unnecessary testing when not actionable. Researchers analyzed more than 7.5 million radiology reports from 1,323,459 patients across two hospitals between 2015 and 2022, comparing a control site with one that implemented targeted interventions. These interventions—radiologist education, a closed-loop tracking tool, and personalized feedback—reduced the rate of additional imaging recommendations from 10 percent to 5.6 percent and increased the proportion of actionable recommendations from 5.6 percent to 42.3 percent, while rates at the control site remained stable. The results highlight the potential for targeted interventions to improve patient safety by reducing diagnostic errors, while also promoting more efficient and appropriate use of imaging across radiologic subspecialties.
https://pubs.rsna.org/doi/10.1148/radiol.243750
Antibiotics Overprescribed for Many Pediatric Infections at Discharge
Only one in five children discharged from the hospital with a diagnosis of infection received optimal prescriptions for antibiotics in both selection and duration, according to an AHRQ-funded study in Infection Control and Hospital Epidemiology. Researchers analyzed electronic health records from 1,206 encounters across four children’s hospitals with antibiotic stewardship programs throughout 2021, including 226 cases of community-acquired pneumonia, 417 urinary tract infections, and 563 skin or soft-tissue infections. They defined optimal prescribing as selecting medications and treatment durations recommended by national and hospital guidelines—for example, a 4- to 6-day course of amoxicillin for pneumonia. Overall, the choice of antibiotic was optimal in 77 percent of encounters, treatment duration was optimal in only 26 percent, and only 20 percent were optimal in choice and duration. The findings point to a need for stewardship interventions that target discharge prescribing, an area often overlooked in current programs.
https://pubmed.ncbi.nlm.nih.gov/40196890/
Statistical Brief Compares Telehealth Use in Metropolitan, Nonmetropolitan Areas
https://meps.ahrq.gov/mepsweb/data_stats/Pub_ProdResults_Details.jsp?pt=Statistical+Brief&opt=1&id=1326
As part of AHRQ’s stated priority to define appropriate and cost-effective use of telehealth, a new statistical brief from the agency’s Medical Expenditure Panel Survey (MEPS) project estimates the use of telehealth services between 2021 and 2023 for both rural and urban patients. Compared with patients in metropolitan areas, nonmetropolitan patients used telehealth services for a significantly smaller percentage of medical visits. While telehealth accounted for just over 26 percent of mental health visits in rural areas, urban patients used telehealth for nearly half of all mental health visits. The statistical brief also estimates telehealth use by insurance type and other patient and provider characteristics.
https://meps.ahrq.gov/mepsweb/
Diagnostic Safety Issue Briefs: Advance Diagnostic Safety With AHRQ’s Evidence-Based Issue Briefs
Diagnostic Safety Issue Briefs: .ib-mini { display: block; position: relative; width: 220px; min-height: 380px; float: left; margin: 10px 10px; padding: 10px 5px 5px 10px; } Starting in 2019, AHRQ supported the development of a series of papers on different diagnostic safety topics. The purpose of the papers was to develop, based on research conducted to date, more resources to improve diagnostic safety and quality, during a time when research to improve diagnostic safety was still an emerging field as compared to research to understand and prevent treatment-related mishaps.
AHRQ’s Diagnostic Safety Issue Briefs provide accessible, evidence-based guidance to support healthcare systems in advancing diagnostic safety and quality. Each brief describes key concepts, examines emerging challenges, and highlights approaches that can be readily applied in practice. Explore the resources below to deepen your understanding and identify strategies that can strengthen diagnostic performance across your organization.
Understanding the AI Wave: Foundational Knowledge for Improving Diagnosis and Beyond demystifies core artificial intelligence concepts and offers real-world examples to build foundational understanding. Grounded in evidence and informed by lessons from other high-risk industries, this issue brief provides practical, actionable guidance for healthcare leaders, clinicians, and patients.
Understanding the AI Wave: Foundational Knowledge for Improving Diagnosis and Beyond
https://www.ahrq.gov/diagnostic-safety/resources/issue-briefs/dxsafety-ai-wave.html
Four Pillars for Sustainable Centers of Excellence was developed to support AHRQ’s Diagnostic Center of Excellence grantees in shaping their sustainability plans. It provides recommendations, examples, and success stories that can benefit any type of Center of Excellence.
Four Pillars for Sustainable Centers of Excellence
https://www.ahrq.gov/diagnostic-safety/resources/issue-briefs/dxsafety-sustainability-centers-of-excellence.html
Exploration of Foundational Terminology and Paradigms for Improving Diagnosis explores different diagnostic terminology and offers questions that can help define which terms and definitions are most suitable for discussions about diagnosis.
Exploration of Foundational Terminology and Paradigms for Improving Diagnosis
https://www.ahrq.gov/diagnostic-safety/resources/issue-briefs/dxsafety-terminology.html
Introducing Academia Global and Public Health Matteo Charles Malvezzi* [1]
https://www.academia.edu/academia-global-and-public-health/1/1/10.20935/AcadPHealth8010
It is my honor to welcome you, the reader and prospective contributor, to Academia Global and Public Health. In this inaugural editorial, I would like to outline the future aims and scope of this journal. But before doing so, let me underscore what we consider to be our highest priority: being an author-centered journal built for scientific readers and contributors. Our mission is to build a bond of trust with our authors and readers. To achieve this, we will strive for quality over quantity, selecting published material with care and ensuring that the peer review process is fair, timely, and constructive.
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act December 2025
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-dispute-resolution-and-administrative-hearings-final-administrative-orders-under-section-505g?utm_medium=email&utm_source=govdelivery
Today, the U.S. Food and Drug Administration issued a final guidance for industry titled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug and Cosmetic Act.”
The guidance provides recommendations on the formal dispute and administrative hearing procedures with respect to final orders under section 505G of the Food, Drug and Cosmetic Act (FD&C Act). It provides recommendations on the procedures, including formal dispute resolution (FDR), for resolving scientific and/or medical disputes between CDER and requestors and sponsors of over-the-counter (OTC) monograph drugs that will be subject to a final order under section 505G of the FD&C Act. This guidance also outlines the procedures for an administrative hearing related to a final order. Finally, it describes the procedures for consolidated proceedings for FDR and hearings to resolve the scientific and/or medical disputes.
FDA committed to issuing a guidance on consolidated proceedings and updating the existing CDER FDR guidance, CDER Formal Dispute Resolution: Sponsor Appeals Above the Division Level (Nov. 2017). For efficiency, rather than amending FDA’s existing FDR guidance to include FDR procedures for final orders and issuing a separate guidance for consolidated proceedings for appeals, FDA is issuing this single draft guidance.
https://www.fda.gov/media/106407/download?utm_medium=email&utm_source=govdelivery
Read the Federal Register notice for additional information.
https://www.federalregister.gov/documents/2025/12/23/2025-23707/formal-dispute-resolution-and-administrative-hearings-of-final-administrative-orders-under-section
For more information, including frequently asked questions about OTC monographs, visit OTC Monographs@FDA.
FDA Expands Flibanserin Approval to Postmenopausal Women With Hypoactive Sexual Desire Disorder ++++
News & Perspectives:
How Old Is ‘Current’ and Why Do Users Confide in Chatbots?
How Old Is ‘Current’ and Why Do Users Confide in Chatbots?
Ute Eppinger
https://www.medscape.com/viewarticle/how-old-current-and-why-do-users-confide-chatbots-2025a100102a?ecd=wnl_edit_tpal_etid7981416&uac=148436CN&impID=7981416
How to Get ChatGPT to Recommend Thalidomide to a Pregnant Woman
How to Get ChatGPT to Recommend Thalidomide to a Pregnant Woman
F. Perry Wilson, MD, MSCE
https://www.medscape.com/viewarticle/how-get-chatgpt-recommend-thalidomide-pregnant-woman-2025a1001010?ecd=wnl_edit_tpal_etid7981416&uac=148436CN&impID=7981416
FDA Expands Flibanserin Approval to Postmenopausal Women With Hypoactive Sexual Desire Disorder
FDA Expands Flibanserin Approval to Postmenopausal Women With Hypoactive Sexual Desire Disorder
Tara Haelle
https://www.medscape.com/viewarticle/fda-expands-flibanserin-approval-postmenopausal-women-2025a100102d?ecd=wnl_edit_tpal_etid7981416&uac=148436CN&impID=7981416
December 23, 2025
You Can’t Bargain-Buy Nursing: Lessons From Milan’s ICU
You Can’t Bargain-Buy Nursing: Lessons From Milan’s ICU
Roberta Villa, MD
https://www.medscape.com/viewarticle/you-cant-bargain-buy-nursing-lessons-milans-icu-2025a100102b?ecd=wnl_edit_tpal_etid7981416&uac=148436CN&impID=7981416
martes, 23 de diciembre de 2025
Trump administration proposes Medicare pilots to lower drug prices on par with peer countries The plans could save Medicare billions and reduce patients’ out-of-pocket costs
https://www.statnews.com/2025/12/22/trump-medicare-demonstrations-most-favored-nation-lower-drug-prices/
By John Wilkerson and Daniel PayneDec. 22, 2025
Pharmaceutical industry evades drug price transparency, again The actual prices paid for prescription drugs will remain out of public view
https://www.statnews.com/2025/12/22/trump-delays-drug-price-transparency-drug-companies-pbm/
By Bob HermanDec. 22, 2025
Business of Health Care Reporter
Trump administration to scrap federal rule requiring transparency into health AI tools The move could make it easier for health systems to adopt AI, while leaving patients vulnerable
https://www.statnews.com/2025/12/22/hhs-proposes-scrapping-ai-model-cards-transparency-rule/
By Casey RossDec. 22, 2025
Chief Investigative Reporter, Data & Technology
4 questions to understand the costs of ‘medical freedom’ Before policymakers change vaccine requirements, they need to ask these questions
https://www.statnews.com/2025/12/23/vaccine-policy-versus-medical-freedom-movement-4-questions/
By Sarah DespresDec. 23, 2025
Despres is a public health expert who served as a counselor to the secretary of Health and Human Services from 2021 to 2025.
China biotech’s Cambrian explosion In China’s biotech sector, hypercompetition and speed are rewriting the rules of drug discovery
https://www.statnews.com/2025/12/23/china-drug-discovery-serendipity-competition/
By Brian FinrowDec. 23, 2025
Finrow is CEO, co-founder, and co-chairman of Lumen Bioscience.
FDA approves pill version of Novo Nordisk’s Wegovy, possibly widening access Oral version led to similar efficacy as the injectable weight loss treatment in clinical trial
https://www.statnews.com/2025/12/22/wegovy-pill-oral-weight-loss-treatment-approved/
By Elaine ChenDec. 22, 2025
National Biotech Reporter
How testosterone fell out of favor in medicine — and how it came back Q&A with the doctor who pioneered modern testosterone treatment in America
https://www.statnews.com/2025/12/23/how-testosterone-treatment-was-rehabilitated-abraham-morgentaler-mens-health/
By Annalisa MerelliDec. 23, 2025
Contributing Writer
How the Trump administration is recasting government’s role in regulating health technology Agencies that used to set up and enforce guardrails now want to drive adoption of new, risky technologies
https://www.statnews.com/2025/12/23/trump-health-tech-ai-regulation/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_jjlyg5GXouoeHlgYjVYsel_KnRRSnogMQRFsXYw4DAz-4PTMaYk9pnmi61ayWn3ETzKp1qIdTc1EaaXkoB9s1qXfPGw&_hsmi=395702425&utm_content=395702425&utm_source=hs_email
By Casey Ross, Mario Aguilar, Katie Palmer, and Brittany TrangDec. 23, 2025
FDA Qualifies Total Hip Bone Mineral Density (BMD) as Surrogate Endpoint for Osteoporosis Drug Development
https://force-dsc.my.site.com/ddt/s/ddt-project?ddtprojectid=97&utm_medium=email&utm_source=govdelivery
FDA Qualifies Total Hip Bone Mineral Density (BMD) as Surrogate Endpoint for Osteoporosis Drug Development
The U.S. Food and Drug Administration (FDA) qualified total hip bone mineral density (BMD) as assessed by dual energy X-ray absorptiometry (DXA) as a validated surrogate endpoint to support clinical trials of investigational therapies for post-menopausal women with osteoporosis at risk for fracture.
Osteoporosis-related fractures represent a major public health challenge, affecting one in two women and one in four men over age 50. Despite the availability of effective FDA-approved therapies, there remains an urgent need for new osteoporosis medications with improved safety profiles and efficacy.
Traditional clinical trials for anti-osteoporosis drugs have required fracture endpoints as primary efficacy measures, necessitating large studies that can take two to five years. Qualifying BMD as a surrogate endpoint would allow for more efficient clinical trials, potentially enabling faster approval of new osteoporosis treatments and improving patient access. A BMD test measures calcium and other minerals in the bones, with more minerals indicating denser bones that are less prone to fracture.
The qualified tool is the percentage change from baseline at 24 months in total hip BMD assessed by DXA. This biomarker can be used as a validated surrogate endpoint for assessment of investigational therapies for post-menopausal women with osteoporosis at risk for fracture in phase 3 clinical trials, providing an alternative to fracture endpoints.
Drug development tools play an important role in bringing new therapies to patients by providing well-defined, scientifically sound approaches to clinical trial design and regulatory decision-making.
Drug Development Tool (DDT) Qualification Programs
https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tool-ddt-qualification-programs
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act December 2025
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-dispute-resolution-and-administrative-hearings-final-administrative-orders-under-section-505g?utm_medium=email&utm_source=govdelivery
FDA Issues Final Guidance About Formal Dispute and Administrative Hearings of Final Orders for OTC Monograph Drugs
Today, the U.S. Food and Drug Administration issued a final guidance for industry titled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug and Cosmetic Act.”
The guidance provides recommendations on the formal dispute and administrative hearing procedures with respect to final orders under section 505G of the Food, Drug and Cosmetic Act (FD&C Act). It provides recommendations on the procedures, including formal dispute resolution (FDR), for resolving scientific and/or medical disputes between CDER and requestors and sponsors of over-the-counter (OTC) monograph drugs that will be subject to a final order under section 505G of the FD&C Act. This guidance also outlines the procedures for an administrative hearing related to a final order. Finally, it describes the procedures for consolidated proceedings for FDR and hearings to resolve the scientific and/or medical disputes.
FDA committed to issuing a guidance on consolidated proceedings and updating the existing CDER FDR guidance, CDER Formal Dispute Resolution: Sponsor Appeals Above the Division Level (Nov. 2017). For efficiency, rather than amending FDA’s existing FDR guidance to include FDR procedures for final orders and issuing a separate guidance for consolidated proceedings for appeals, FDA is issuing this single draft guidance.
New Trump Administration Proposals Would Further Limit Gender Affirming Care for Young People by Restricting Providers and Reducing Coverage Authors: Lindsey Dawson and Scott Hulver Published: Dec 22, 2025
https://www.kff.org/lgbtq/new-trump-administration-proposals-would-further-limit-gender-affirming-care-for-young-people-by-restricting-providers-and-reducing-coverage/?utm_campaign=31978628-KFF-LGBTQ&utm_medium=email&_hsenc=p2ANqtz--9OXbX068T4x1UQ0OVUMEhdhUc-FrWGHcTYf095Oy_ws7FZTfQwaPHPWn9E6c2vG4FZQ2wLHrWIOf9UlFSui95XXXCIg&_hsmi=395626533&utm_content=395626533&utm_source=hs_email
Examining Newly Proposed Federal Rules That Would Further Limit Youth Access to Gender Affirming Care
Following the release of two proposed federal rules that aim to further limit youth access to gender affirming care, KFF examines what they include and what they could mean for transgender youth who seek this care, and for their providers. These rules align with a Trump Administration Executive Order released earlier this year and build on a range of other state and administrative actions intended to limit access to gender affirming care.
One proposed rule prohibits the provision of certain gender affirming care services as a condition of hospital participation in Medicare and Medicaid. The KFF brief reviews the implications, which include restricting care access in most hospitals, including for patients with private insurance. With Medicare and Medicaid accounting for almost half of spending on care in hospitals, if the rule were finalized, hospitals are unlikely to continue providing gender affirming care.
The other proposed rule would ban federal Medicaid and Children's Health Insurance Program payments for the same types of care across all providers (not just hospitals). As the KFF brief explains, this proposed rule would have a significant — though uneven — impact on access, limiting coverage for families who would find paying for gender affirming care out-of-pocket most challenging.
The public has 60 days to comment on the rules, after which the administration could modify or take action to finalize them. If finalized, they are likely to face legal challenges.
CONTACT:
Craig Palosky | 202.654.1369| CraigP@kff.org
Expat MD: The Ultimate Guide to Working Abroad
https://www.medscape.com/viewcollection/37936?ecd=spec-page_expatmd
Physicians are increasingly trading familiar turf for new challenges and opportunities. With nearly 19% of doctors in OECD countries now foreign-trained — and migration rising — this collection explores how doctors from around the world make the leap abroad, what regulatory hurdles await them, and what life really looks like once they land. Dive into detailed country guides and frank personal stories of ambition, adaptation, and the unexpected.
lunes, 22 de diciembre de 2025
EURORDIS welcomes the Commission’s ‘promising’ Biotech Act I December 2025
EURORDIS welcomes the Commission’s ‘promising’ Biotech Act I
December 2025
16 December 2025, Strasbourg – While EURORDIS–Rare Diseases Europe will take more time to analyse the European Commission’s Biotech Act I proposals in detail, we welcome this important step towards strengthening Europe’s capacity to innovate in health and translate scientific progress into tangible benefits for society.
https://www.eurordis.org/eurordis-welcomes-commissions-biotech-act-i/
There is No Drop-Dead Date for an ACA Tax Credit Extension, But Coverage Losses Will Mount as the Clock Ticks
https://www.kff.org/quick-take/there-is-no-drop-dead-date-for-an-aca-tax-credit-extension-but-coverage-losses-will-mount-as-the-clock-ticks/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-927xI3WG7ee7INSs2sWhiapU7sm9n-qYlBJnIPFM1DDog3GmV6ipeFlpCs9enowng484ee_OkhmDhsh-Rf0Vqao9TGWA&_hsmi=395312363&utm_content=395312363&utm_source=hs_email
A discharge petition in the House paves the way for a vote on a three-year extension of the tax credits, which would provide ACA enrollees premium relief whenever it comes. While there is still time to extend the enhanced tax credits, with each passing day, more and more ACA Marketplace enrollees are going to drop their health insurance when faced with eye-popping increases in their premium payments, writes KFF’s Larry Levitt.
Mass General Brigham bolstered its bottom line. Other Mass. hospital groups reported multimillion losses The different finances and outlooks of the hospitals in the state are mirrored nationwide
https://www.statnews.com/2025/12/21/mass-general-brigham-finances/
By Jessica Bartlett — Boston GlobeDec. 21, 2025
A seasoned biotech VC looks to 2026 and sees a wave of IPOs coming Atlas Venture’s Bruce Booth believes more drugmakers are ready to access public markets
https://www.statnews.com/2025/12/22/biotech-public-companies-ipos/
By Allison DeAngelisDec. 22, 2025
Biotech Startups and Venture Capital Reporter
Researchers have a moral obligation to push back when their studies are twisted to promote false health claims Studies give a gloss of authenticity to bogus ideas. Researchers must fight back
https://www.statnews.com/2025/12/22/research-misrepresented-vaccines-newsguard/
By John GregoryDec. 22, 2025
Gregory is health editor for NewsGuard.
3 key issues to watch at FDA as Makary struggles to stabilize the agency What’s the future of the FDA’s leader? And how will oversight of vaccines and drugs change?
https://www.statnews.com/2025/12/22/fda-2026-outlook-commissioner-makary-future-vaccine-policy-deregulation/
By Lizzy LawrenceDec. 22, 2025
FDA Reporter
American food safety could be headed for a breakdown By Sarah ToddDec. 22, 2025 Reporter, Commercial Determinants of Health
American food safety could be headed for a breakdown
Food safety experts warn that federal cuts will leave people more vulnerable to foodborne illness
https://www.statnews.com/2025/12/22/american-food-safety-funding-cuts-foodnet/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9xiybqrJkoIJ6Ae-zjY6dRBOPLhN3Tm96SjgzY_W02j4CurCvasHgTW-ydCJd8igtdzq-3TvsIvS7uy_FUKIhigEbCVg&_hsmi=395375684&utm_content=395375684&utm_source=hs_email
Morning Briefing: Today's News Summaries Monday, Dec 22 2025 UPDATED 9:24 AM +++++++
Morning Briefing: Today's News Summaries
Monday, Dec 22 2025 UPDATED 9:24 AM
With ACA Prices Set To Soar, Trump Pushes Health Insurers To Lower Costs
With ACA Prices Set To Soar, Trump Pushes Health Insurers To Lower Costs
President Donald Trump said Friday that he would meet with insurance companies soon to pressure them to lower patients' prices, Bloomberg reported. Insurance companies “are making so much money, and they have to make less, a lot less,” Trump said. In other news, CMS has created an Office of Rural Health Transformation to oversee the $50 billion Rural Health Transformation Program.
https://kffhealthnews.org/morning-breakout/with-aca-prices-set-to-soar-trump-pushes-health-insurers-to-lower-costs/
Nine Drugmakers Agree To Trump's 'Most-Favored-Nation' Pricing Deal
Nine Drugmakers Agree To Trump’s ‘Most-Favored-Nation’ Pricing Deal
The deal requires the pharmaceutical companies to match what they charge in other developed countries for newly launched medications, including in commercial and cash-pay markets, as well as Medicare and Medicaid.
https://kffhealthnews.org/morning-breakout/nine-drugmakers-agree-to-trumps-most-favored-nation-pricing-deal/
UnitedHealth Releases First External Review In Bid To Regain Public Trust
UnitedHealth Releases First External Review In Bid To Regain Public Trust
UnitedHealth has pledged to take close to two dozen specific actions across the areas in which the report found it lacking, including unresolved issues regarding patient care management, and prior authorizations. Plus, several Illinois hospitals with religious ties spurn medical aid-in-dying law.
https://kffhealthnews.org/morning-breakout/unitedhealth-releases-first-external-review-in-bid-to-regain-public-trust/
HPV Vaccines Prevent Much More Than Cervical Cancer, Study Finds
HPV Vaccines Prevent Much More Than Cervical Cancer, Study Finds
The research, published in JAMA Oncology, found that the rate of precancerous vulvar or vaginal lesions was 37% lower in those who'd gotten at least one dose of HPV vaccine. Also: proton beam radiation therapy, mpox, and more.
https://kffhealthnews.org/morning-breakout/hpv-vaccines-prevent-much-more-than-cervical-cancer-study-finds/
Seasonal Viruses On The Rise As Holiday Travel Increases
Seasonal Viruses On The Rise As Holiday Travel Increases
As one of the busiest travel weeks begins, cases of flu, norovirus, and covid are on the upswing nationwide. Also: The CDC has reported two new flu-related deaths in children and nearly 5 million cases of influenza across the U.S.
https://kffhealthnews.org/morning-breakout/seasonal-viruses-on-the-rise-as-holiday-travel-increases/
As Children Wait For Care, Lawsuit Delays Florida's KidCare Expansion
As Children Wait For Care, Lawsuit Delays Florida’s KidCare Expansion
Florida lawmakers unanimously passed the expansion two years ago, but an ongoing lawsuit Florida filed against CMS stands in its way. Other news from around the nation comes from Minnesota, Maryland, Colorado, California, and Louisiana.
https://kffhealthnews.org/morning-breakout/as-children-wait-for-care-lawsuit-delays-floridas-kidcare-expansion/
Viewpoints: Why Republicans Remain Divided On Health Care; Vaccines, Measles, And Future Of Public Health
https://kffhealthnews.org/morning-breakout/viewpoints-why-republicans-remain-divided-on-health-care-vaccines-measles-and-future-of-public-health/
Fatigue and Sleepiness of Clinicians Due to Hours of Service
https://effectivehealthcare.ahrq.gov/products/fatigue-sleepiness/rapid-research
AHRQ EPC Grand Round: Workplace Safety and Wellbeing
Join a virtual session of the AHRQ Evidence-based Practice Center (EPC) Program Grand Rounds. The series highlights the work of the EPC Program, which promotes and facilitates the use of evidence in health care decisions. Presenters include EPC report authors, along with industry experts, who will weigh in on gaps in the evidence and implications for the field. The session on January 20, from 1 p.m.—3 p.m. ET will focus on the following four EPC reports about workplace safety and wellbeing, with the goal of expanding awareness and implementation of their findings.
https://cma.ahrq.gov/cma/welcome.jsp?code=workplacesafetyandwellbeing
Measuring Documentation Burden in Healthcare
https://effectivehealthcare.ahrq.gov/products/documentation-burden/prepub-tech-brief
AHRQ EPC Grand Round: Workplace Safety and Wellbeing
Join a virtual session of the AHRQ Evidence-based Practice Center (EPC) Program Grand Rounds. The series highlights the work of the EPC Program, which promotes and facilitates the use of evidence in health care decisions. Presenters include EPC report authors, along with industry experts, who will weigh in on gaps in the evidence and implications for the field. The session on January 20, from 1 p.m.—3 p.m. ET will focus on the following four EPC reports about workplace safety and wellbeing, with the goal of expanding awareness and implementation of their findings.
https://cma.ahrq.gov/cma/welcome.jsp?code=workplacesafetyandwellbeing
Mental Health and Occupational Stress in the Emergency Medical Services and 911 Workforces
Mental Health and Occupational Stress in the Emergency Medical Services and 911 Workforces: We addressed four Key Questions (KQs) related to: incidence, prevalence, and severity of mental health and occupational stress issues (KQ1); benefits and harms of interventions to promote resistance and resilience regarding these issues (KQ2); contextual and implementation factors of studies with effective EMS and telecommunicator workforces practices to prevent, recognize, and treat mental health and occupational stress issues (KQ3); and future research that is needed to close existing gaps regarding prevention, recognition, and treatment of mental health issues and occupational stress issues in the EMS and telecommunicator workforces (KQ4).
AHRQ EPC Grand Round: Workplace Safety and Wellbeing
Join a virtual session of the AHRQ Evidence-based Practice Center (EPC) Program Grand Rounds. The series highlights the work of the EPC Program, which promotes and facilitates the use of evidence in health care decisions. Presenters include EPC report authors, along with industry experts, who will weigh in on gaps in the evidence and implications for the field. The session on January 20, from 1 p.m.—3 p.m. ET will focus on the following four EPC reports about workplace safety and wellbeing, with the goal of expanding awareness and implementation of their findings.
https://cma.ahrq.gov/cma/welcome.jsp?code=workplacesafetyandwellbeing
domingo, 21 de diciembre de 2025
White House unveils largest batch of drug pricing agreements yet With nine more deals, only three other drugmakers pressed by Trump have yet to announce pacts
https://www.statnews.com/2025/12/19/trump-drug-prices-new-medicaid-deals-nine-pharmaceutical-companies/
By Daniel Payne and John WilkersonDec. 19, 2025
Kennedy vaccine adviser to take a new role at CDC on children’s health research William Thompson is expected to take a temporary promotion to oversee research around adverse events
https://www.statnews.com/2025/12/19/william-thompson-cdc-rfk-adviser/
By Daniel PayneDec. 19, 2025
Washington Correspondent
Drugmakers promise to stockpile certain drugs as part of new drug pricing deals Few details are available, including whether companies are sending products to the government or maintaining their own reserves
https://www.statnews.com/2025/12/19/drugmakers-stockpile-certain-drugs-most-favored-nation-deals/
By John WilkersonDec. 19, 2025
Washington Correspondent
Why Denmark’s vaccine schedule works for Denmark — but not for the United States The two countries have fundamentally different health care systems and disease burdens
https://www.statnews.com/2025/12/19/denmark-vaccine-schedule-vs-us/
By Jake ScottDec. 19, 2025
Scott, is an infectious diseases physician and clinical associate professor of infectious diseases at Stanford University School of Medicine.
UnitedHealth proclaims audits show it has ‘robust’ procedures, in contrast to findings of independent reviews Government and other independent analyses have offered less rosy view
https://www.statnews.com/2025/12/19/unitedhealth-group-audits-medicare-advantage-upcoding-optum-rx-discounts/
By Tara Bannow and Bob HermanDec. 19, 2025
Urgent need for infection prevention and control in prisons The Lancet Infectious Diseases + +... ++
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(25)00732-7/fulltext?dgcid=raven_jbs_etoc_email
Jan 2026
Volume 26Number 1p1-110, e1-e76
https://www.thelancet.com/journals/laninf/issue/vol26no1/PIIS1473-3099(25)X0013-X
Tackling antimicrobial resistance in people who are immunocompromised: leveraging diagnostic and antimicrobial stewardship
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(25)00311-1/abstract?dgcid=raven_jbs_etoc_feature_laninf
Effectiveness of the TAK-003 dengue vaccine in adolescents during the 2024 outbreak in São Paulo, Brazil: a test-negative, case–control study
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(25)00382-2/abstract?dgcid=raven_jbs_etoc_feature_laninf
Editorial A sustainable primary care approach for obesity The Lancet Primary Care +... ++ +...
Editorial
A sustainable primary care approach for obesity
The Lancet Primary Care
https://www.thelancet.com/journals/lanprc/issue/vol1no5/PIIS3050-5143(25)X0006-6
Social isolation and access to cognitive disorder-related prespecialist care among older people: a 10-year nationwide cross-sectional study from the French National Alzheimer Database
https://www.thelancet.com/journals/lanprc/article/PIIS3050-5143(25)00058-5/fulltext?dgcid=hubspot_email_infocusalerts-neurology_feature&utm_campaign=infocusalerts-neurology&utm_medium=email&_hsenc=p2ANqtz-8W_0GNXL3yPwcZfdoODxJU5GgitrxoeTXnPoOfe2zoW5Q1kBq0BC3Kd11ekZTtFglRrjmAOec-E9OsjF6RrYv8snclSQ&_hsmi=395324206&utm_content=395110203&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=hubspot_email_infocusalerts-neurology_feature&utm_campaign=infocusalerts-neurology&utm_medium=email&_hsenc=p2ANqtz-9S0gPvy-3PLF-guISRG8kOrJ8Kl9XsT9gYxW4W_tJgGXF8ylI5QkLJeCex_TQaLDIDXy2_tslSJFcN1qzLNp-H3RgWPA&_hsmi=395324206&utm_content=395110203&utm_source=hs_email
Editorial
p987
Celebrating decades of progress in Lewy bodies research
The Lancet Neurology
https://www.thelancet.com/journals/laneur/issue/vol24no12/PIIS1474-4422(25)X0012-0
2025: an annus horribilis for health in the USA The Lancet +... ++... +...
2025: an annus horribilis for health in the USA
The Lancet
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02588-7/fulltext?dgcid=raven_jbs_etoc_email
Amylin and the renin-angiotensin system: risk or opportunity in amylin-based therapy?
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01776-3/abstract?dgcid=raven_jbs_etoc_feature_lancet
Home
Donna Wakefield, MBChB, MClinRes, FRCP Edin
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02467-5/abstract?dgcid=raven_jbs_etoc_feature_lancet
Dec 20, 2025
Volume 406Number 10522p2865-2990
https://www.thelancet.com/journals/lancet/issue/vol406no10522/PIIS0140-6736(25)X0051-9
Food & Ag Daily Digest +++++
Food & Ag Daily Digest
News from Around the Web
Okay, but not nearly enough: EU’s loosened restrictions on CRISPR and other gene-edited crops help, but it’s still a wasteful long-haul for approvals
Augustus Bambridge-Sutton | Food Navigator
https://geneticliteracyproject.org/2025/12/19/okay-but-not-nearly-enough-eus-loosened-restrictions-on-crispr-and-other-gene-edited-crops-help-but-its-still-a-wasteful-long-haul-for-approvals/
Discovery of growth ‘switch’ in cold-hardy plants could unlock pathways to develop more cold-resilient crops
Insha Naureen | Food Ingredients 1st
https://geneticliteracyproject.org/2025/12/19/discovery-of-growth-switch-in-cold-hardy-plants-could-unlock-pathways-to-develop-more-cold-resilient-crops/
CRISPR chicken: Could gene editing be the key to cheaper poultry?
BioSpace
https://geneticliteracyproject.org/2025/12/19/crispr-chicken-could-gene-editing-be-the-key-to-cheaper-poultry/
Europe’s veggie burger wars: Farmer backlash against plant-based labeling restrictions stall
RTE
https://geneticliteracyproject.org/2025/12/18/europes-veggie-burger-wars-farmer-backlash-against-plant-based-labeling-restrictions-stall/
Corporate control, ecological challenges and food safety: Challenges await expansion of the gene-editing crop revolution
Bioengineer
https://geneticliteracyproject.org/2025/12/18/corporate-control-ecological-challenges-and-food-safety-challenges-await-expansion-of-the-gene-editing-crop-revolution/
Human Daily Digest +++++
Human Daily Digest
News from Around the Web
Viewpoint: Crazy left meets crazy right—The tort machine created by activist environmentalists to target aspartame, Gardasil, and glyphosate is now turning its sights on vaccines and other MAHA pet grieves
Barbara Pfeffer Billauer | ACSH | December 19, 2025
https://geneticliteracyproject.org/2025/12/19/viewpoint-crazy-left-meets-crazy-right-the-tort-machine-created-by-activist-environmentalists-to-target-aspartame-gardasil-and-glyphosate-is-now-turning-its-sights-on-vaccines-and-other-mah/
AI hype takes a hit—For most businesses, the revolutionary tool falls short
Will Douglas Heaven | MIT Technology Review
https://geneticliteracyproject.org/2025/12/19/ai-hype-takes-a-hit-for-most-businesses-the-revolutionary-tool-falls-short/
Viewpoint: ‘Increasingly futile’—Why debating MAHA influencers with science and reason doesn’t work
Jessica Grose | New York Times
https://geneticliteracyproject.org/2025/12/19/viewpoint-increasingly-futile-why-debating-maha-influencers-with-reason-and-science-doesnt-work/
AI morality? Don’t hold your breath
De Kai | MIT Press Reader
https://geneticliteracyproject.org/2025/12/18/ai-morality-dont-hold-your-breath/
New U.S. cancer policy head falsely believes COVID vaccines ‘turbocharge’ cancer and horse dewormer ivermectin is a miracle drug
David Gilbert | Wired
https://geneticliteracyproject.org/2025/12/18/new-u-s-cancer-policy-head-falsely-believes-covid-vaccines-turbocharge-cancer-and-horse-dewormer-ivermectin-is-a-miracle-drug/
AHRQ CAHPS Research Meeting on “Strengthening Partnerships with Patients and Families to Assess and improve the Experience of Care”
Now Available: Presentations from AHRQ CAHPS Virtual Research Meeting on “Strengthening Partnerships with Patients and Families to Assess and Improve the Experience of Care”
On September 18, AHRQ’s Consumer Assessment of Healthcare Providers and Systems (CAHPS®) program hosted a virtual research meeting focused on the integral role of patients and families in the development and implementation of care experience assessments and quality improvement strategies.
https://www.ahrq.gov/cahps/index.html
The CAHPS Research Meeting shared current research and best practices related to the following questions:
https://www.ahrq.gov/cahps/news-and-events/research-meetings/index.html
How can creative participatory design methods strengthen patient and family involvement?
What collaborative roles can patients and families play to better capture their healthcare experiences?
How could various patient engagement strategies be used to collaboratively improve the design and effectiveness of CAHPS measurement tools?
How can healthcare teams most effectively focus on the healthcare experiences that matter most to patients and families in quality improvement efforts?
Maura Cass, a former partner and head of Health at the award-winning global design firm IDEO, presented the keynote address entitled “Design With, Not For: Building Capacity for Meaningful, Human-Centered Design.”
https://www.ahrq.gov/cahps/news-and-events/research-meetings/2025-research-meeting.html
Access slide presentations and video replays, as well as an event summary.
https://www.ahrq.gov/sites/default/files/wysiwyg/cahps/news-and-events/events/research-meetings/2025_research_meeting_summary.pdf
For questions, please contact the CAHPS User Network at cahps1@westat.com or 1-800-492-9261.
sábado, 20 de diciembre de 2025
A Snapshot of Sources of Coverage Among Medicare Beneficiaries Authors: Nancy Ochieng, Juliette Cubanski, and Tricia Neuman
A Snapshot of Sources of Coverage Among Medicare Beneficiaries
Most in Traditional Medicare Have Supplemental Coverage that Helps Cover Medicare Cost Sharing but More Than Three Million Don’t
Authors: Nancy Ochieng, Juliette Cubanski, and Tricia Neuman
Published: Dec 19, 2025
https://www.kff.org/medicare/a-snapshot-of-sources-of-coverage-among-medicare-beneficiaries/
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 bioethics, surrogacy, football helmets, obesity, and California's CARE Court.
https://kffhealthnews.org/morning-breakout/longer-looks-interesting-reads-you-might-have-missed-245/
Minnesota Fraud Inquiry Extends To 14 Medicaid-Funded Social Programs
Minnesota Fraud Inquiry Extends To 14 Medicaid-Funded Social Programs
Previously, federal prosecutors had been looking into only three safety net programs run by state agencies. Other news comes from Connecticut, Massachusetts, New York, Iowa, Wyoming, Rhode Island, Hawaii, and Pennsylvania.
https://kffhealthnews.org/morning-breakout/minnesota-fraud-inquiry-extends-to-14-medicaid-funded-social-programs/
California Hospital To Shutter Pediatric Unit, Creating Care Desert For Kids
California Hospital To Shutter Pediatric Unit, Creating Care Desert For Kids
Providence Santa Rosa Memorial Hospital will stop admitting patients on March 27. Other health industry news is about remote patient monitoring, no deal in the Virtua Health-ChristianaCare merger, a nursing home bankruptcy, and more.
https://kffhealthnews.org/morning-breakout/california-hospital-to-shutter-pediatric-unit-creating-care-desert-for-kids/
Wildfire Fighters Who Develop Cancer Eligible For One-Time $450,000 Payout
Wildfire Fighters Who Develop Cancer Eligible For One-Time $450,000 Payout
The law signed by President Trump on Thursday also provides college tuition for their family if they die or become debilitated from a smoke-related cancer. Plus: The "warrior dividend" announced for troops will be paid out of the military housing stipend already approved by Congress.
https://kffhealthnews.org/morning-breakout/wildfire-fighters-who-develop-cancer-eligible-for-one-time-450000-payout/
ACA Subsidies, Funding Bill Punted To Next Year As Congress Takes A Break
ACA Subsidies, Funding Bill Punted To Next Year As Congress Takes A Break
The enhanced tax credits that millions of Americans rely on to pay for health insurance on the Obamacare marketplace will expire Dec. 31, meaning premiums could soar. When Congress meets again, it'll have mere weeks to pass funding legislation to avoid another government shutdown.
https://kffhealthnews.org/morning-breakout/aca-subsidies-funding-bill-punted-to-next-year-as-congress-takes-a-break/
CMS’ Attempt To Strip Hospital Funds Over Trans Care Could Take A While
CMS’ Attempt To Strip Hospital Funds Over Trans Care Could Take A While
On Thursday, the Centers for Medicare and Medicaid Services unveiled two rules to withhold federal funds from facilities that provide gender-affirming care for trans minors, but the public will have 60 days to comment on the proposals. With a large number of comments expected, it could take months or even a year to finalize the rules, one attorney told STAT.
https://kffhealthnews.org/morning-breakout/cms-attempt-to-strip-hospital-funds-over-trans-care-could-take-a-while/
With Cannabis Reclassification, CBD Will Be Covered For Medicare Patients
With Cannabis Reclassification, CBD Will Be Covered For Medicare Patients
President Donald Trump's executive order effectively speeds up the process to reclassify marijuana as a Schedule III substance, a move that opens up access to Americans who want it and for researchers studying its medical use. Marijuana is still illegal under federal law.
https://kffhealthnews.org/morning-breakout/with-cannabis-reclassification-cbd-will-be-covered-for-medicare-patients/
viernes, 19 de diciembre de 2025
Biotech’s year in review ++
https://www.statnews.com/2025/12/18/readout-loud-podcast-biotech-venture-capital-obesity-coverage/
By Allison DeAngelis, Elaine Chen, and Adam FeuersteinDec. 18, 2025
In major effort to end gender-affirming care, Trump administration takes aim at hospitals
Proposed rules threaten financial consequences for clinics providing such care to trans minors
https://www.statnews.com/2025/12/18/transgender-care-hospitals-trump-cms-rules/
By Theresa Gaffney, Daniel Payne, and Chelsea CirruzzoDec. 18, 2025
NIH funding rates for early-career researchers plunged in 2025, new data show Change in how grants are paid undercut support for young scientists, an agency priority
https://www.statnews.com/2025/12/18/nih-early-career-researchers-grant-success-rate-falls/
By Anil Oza and Jonathan WosenDec. 18, 2025
Trump’s marijuana reclassification could boost research, broaden access President weighs in on debate between hard-liners and those who want more research on drug’s medical uses
https://www.statnews.com/2025/12/18/trump-reclassifies-marijuana-to-boost-research-and-access/
By Lev FacherDec. 18, 2025
Addiction Reporter
Facing federal hostility, supervised consumption site points to 1,900 overdose reversals New York officials show support for OnPoint even as Trump administration criticizes harm reduction
https://www.statnews.com/2025/12/18/on-point-nyc-drug-consumption-site-trump-defiance/
By Lev FacherDec. 18, 2025
Addiction Reporter
5 lessons for U.S. research funding from the AIDS crisis Medicine can’t wait for Washington
https://www.statnews.com/2025/12/19/aids-research-federal-funding-cuts-lessons/
By Robert B. ShpinerDec. 19, 2025
Shpiner is a clinical professor of medicine (pulmonary and critical care) at the UCLA David Geffen School of Medicine.
U.K.’s state-owned investment bank shows up in the U.S., eager to spend on biotech British Business Bank has billions to put into life sciences VC firms and startups, other key sectors
https://www.statnews.com/2025/12/19/uk-biotech-life-sciences-investment/
By Allison DeAngelisDec. 19, 2025
Biotech Startups and Venture Capital Reporter
I’m the former head of Pfizer R&D. I’m very worried about biopharma’s future The New York Times once called me ‘Dr. Optimistic.’ I’m not so optimistic now
https://www.statnews.com/2025/12/19/pharmaceutical-industry-future-rfk-jr-trump/
By John L. LaMattinaDec. 19, 2025
LaMattina is the former president of Pfizer Global R&D and is currently a senior director at PureTech Health.
CDC awards grant to controversial Danish researchers with ties to top FDA official Experts have questioned the ethics and utility of study on the hepatitis B vaccine birth dose
https://www.statnews.com/2025/12/18/cdc-grant-controversial-researchers-ties-to-tracy-beth-hoeg/
By Lizzy Lawrence and Helen BranswellDec. 18, 2025
FDA voucher program has become vehicle for political interference in drug review decisions, staffers say Initiative is seen as having fast-tracked process at expense of career scientists’ expertise
https://www.statnews.com/2025/12/19/fda-voucher-program-political-interference/
By Lizzy LawrenceDec. 19, 2025
FDA Reporter
jueves, 18 de diciembre de 2025
AI morality? Don’t hold your breath De Kai | MIT Press Reader | December 18, 2025 +++++ +++++
https://geneticliteracyproject.org/2025/12/18/ai-morality-dont-hold-your-breath/
New U.S. cancer policy head falsely believes COVID vaccines ‘turbocharge’ cancer and horse dewormer ivermectin is a miracle drug
David Gilbert | Wired
https://geneticliteracyproject.org/2025/12/18/new-u-s-cancer-policy-head-falsely-believes-covid-vaccines-turbocharge-cancer-and-horse-dewormer-ivermectin-is-a-miracle-drug/
Hype adjustment: Probiotic supplements don’t help much to improve your gut function and overall health, and are a waste of money
Lydia Denworth | Scientific American
https://geneticliteracyproject.org/2025/12/18/hype-adjustment-probiotic-supplements-dont-help-much-to-improve-your-gut-function-and-overall-health-and-are-a-waste-of-money/
Alert to Donald Trump: Tanning bed users at higher risk for skin cancer
Maria Godoy | NPR
https://geneticliteracyproject.org/2025/12/17/alert-to-donald-trump-tanning-bed-users-at-higher-risk-for-skin-cancer/
What diseases lurk in your DNA? AI has many new answers
Mount Sinai
https://geneticliteracyproject.org/2025/12/17/what-diseases-lurk-in-your-dna-ai-has-many-new-answers/
Europe’s veggie burger wars: Farmer backlash against plant-based labeling restrictions stall
RTE
https://geneticliteracyproject.org/2025/12/18/europes-veggie-burger-wars-farmer-backlash-against-plant-based-labeling-restrictions-stall/
Corporate control, ecological challenges and food safety: Challenges await expansion of the gene-editing crop revolution
Bioengineer
https://geneticliteracyproject.org/2025/12/18/corporate-control-ecological-challenges-and-food-safety-challenges-await-expansion-of-the-gene-editing-crop-revolution/
The expanding role of robotics in agriculture … on Earth and in space
Alice Carnevali | inkl
https://geneticliteracyproject.org/2025/12/17/the-expanding-role-of-robotics-in-agriculture-on-earth-and-in-space/
Bitter dark chocolate appears to slow the aging process
Tibi Puiu | ZME Science
https://geneticliteracyproject.org/2025/12/17/bitter-dark-chocolate-appears-to-slow-the-aging-process/
Fungus ‘meat’? Yes, it could be a less expensive, environmentally sustainable —and tasty— chicken substitute
Vishwam Sankaran | inkl
https://geneticliteracyproject.org/2025/12/16/fungus-meat-yes-it-could-be-a-less-expensive-environmentally-sustainable-and-tasty-chicken-substitute/
ACIP Vote Drives Online Engagement About Hepatitis B Vaccine, And Posts Claim a VAERS “Cover-Up” of COVID-19 Vaccine Deaths Irving Washington , Hagere Yilma , and Joel Luther
https://www.kff.org/health-information-trust/acip-vote-drives-online-engagement-about-hepatitis-b-vaccine-and-posts-claim-a-vaers-cover-up-of-covid-19-vaccine-deaths/
Nearly two weeks after a CDC vaccine advisory panel voted to end the universal recommendation that newborns be vaccinated for hepatitis B, online conversations about childhood vaccination schedules and parental choice have continued at elevated levels, with many prominent accounts celebrating the decision as a victory for medical freedom.
Meanwhile, narratives about an FDA memo claiming COVID-19 vaccines caused 10 pediatric deaths have evolved from focusing on the unverified claims to framing the announcement as evidence of a broader government “cover-up,” as some have characterized it as vindication for those previously “silenced” for raising vaccine safety concerns.
Morning Briefing: Today's News Summaries Thursday, Dec 18 2025 UPDATED 9:35 AM ++++++ ++
Morning Briefing: Today's News Summaries
Thursday, Dec 18 2025 UPDATED 9:35 AM
House OKs GOP Health Care Bill Without Extending ACA Subsidies
House OKs GOP Health Care Bill Without Extending ACA Subsidies
The vote was 216-211, but four Republicans have joined with Democrats in trying to force a vote on an extension of the ACA subsidies. Meanwhile, Affordable Care Act exchanges brace for chaos
https://kffhealthnews.org/morning-breakout/house-oks-gop-health-care-bill-without-extending-aca-subsidies/
Anti-Transgender Bill Passes House; RFK Jr. Could Announce Restrictions
Anti-Transgender Bill Passes House; RFK Jr. Could Announce Restrictions
Meanwhile in Texas, the Department of Public Safety is amassing a list of transgender Texans using data from their driver's licenses, and the state has opened a public tip line designed to help enforce the state’s “bathroom bill."
https://kffhealthnews.org/morning-breakout/anti-transgender-bill-passes-house-rfk-jr-could-announce-restrictions/
HHS Rescinds Millions In Grants Given To American Academy Of Pediatrics
HHS Rescinds Millions In Grants Given To American Academy Of Pediatrics
The Trump administration said it is clawing back grants that “no longer align with the department’s mission or priorities.” The academy has been critical of how the Department of Health and Human Services under Secretary Robert F. Kennedy Jr. has approached vaccine policy.
https://kffhealthnews.org/morning-breakout/hhs-rescinds-millions-in-grants-given-to-american-academy-of-pediatrics/
Nebraska Medicaid Work Requirements Will Start May 1, Ahead Of Schedule
Nebraska Medicaid Work Requirements Will Start May 1, Ahead Of Schedule
The Cornhusker State will be the first to fall in line with the Trump administration's law that mandates 80 hours of work or community service each month, or part-time school enrollment for people 19 to 64 who have Medicaid coverage. States have until 2027 to implement that policy
https://kffhealthnews.org/morning-breakout/nebraska-medicaid-work-requirements-will-start-may-1-ahead-of-schedule/
NEJM Evidence, CIDRAP Issue First 'Public Health Alerts' To Fill Data Gaps
NEJM Evidence, CIDRAP Issue First ‘Public Health Alerts’ To Fill Data Gaps
The joint report discussed mpox and H3N2 influenza. The collaboration aims to provide "timely, evidence-based alerts that can help local and state health leaders act quickly to protect the health of people in their communities,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota.
https://kffhealthnews.org/morning-breakout/nejm-evidence-cidrap-issue-first-public-health-alerts-to-fill-data-gaps/
Study Shows High-Fat Cheese, Cream May Help Lower Dementia Risk
Study Shows High-Fat Cheese, Cream May Help Lower Dementia Risk
The researchers note that no difference was seen for low-fat milk products, or whole milk, and that what the cows eat is also important. Other lifestyle and health news looks at warning signs of dementia; blood tests for Alzheimer's; "holiday heart syndrome;" and more.
https://kffhealthnews.org/morning-breakout/study-shows-high-fat-cheese-cream-may-help-lower-dementia-risk/
Research Roundup: The Latest Science, Discoveries, And Breakthroughs
Each week, KFF Health News compiles a selection of health policy studies and briefs.
https://kffhealthnews.org/morning-breakout/research-roundup-the-latest-science-discoveries-and-breakthroughs-49/
Viewpoints: States Are Vital To Protecting Vaccine Access; Informed Debate With MAHA Mavens Is Futile
https://kffhealthnews.org/morning-breakout/viewpoints-states-are-vital-to-protecting-vaccine-access-informed-debate-with-maha-mavens-is-futile/
Securing Smart Speakers for Home Health Care: NIST Offers New Guidelines December 17, 2025
https://www.nist.gov/news-events/news/2025/12/securing-smart-speakers-home-health-care-nist-offers-new-guidelines
Smart speakers are commonly used to answer questions, control thermostats and play music. Now consumers are calling on them for home health care — to talk to a provider, refill a prescription or schedule an appointment. Telehealth can benefit patients, but the threats are numerous as well: An attacker could alter a prescription, steal confidential medical data or connect the patient to an impostor.
To reduce the cybersecurity risks these interactions carry, the National Institute of Standards and Technology (NIST) has released guidelines that can help protect patients and providers alike.
Biotech, growing up, is turning profitable Plus: A chat with Jared Holz, Mizuho’s health care market strategist By Adam FeuersteinDec. 18, 2025 Senior Writer, Biotech
https://www.statnews.com/2025/12/18/biotech-growing-up-is-turning-profitable/
By Adam FeuersteinDec. 18, 2025
Senior Writer, Biotech
House passes health care bill to boost access to workplace insurance
GOP bill doesn’t address expiring ACA subsidies, but is aimed at curbing insurance costs
By John WilkersonDec. 17, 2025
Washington Correspondent
https://www.statnews.com/2025/12/17/house-passes-health-care-bill-workplace-insurance/
Meta is urged by state attorneys general to boost enforcement of weight loss drug advertising
State AGs claim a ‘surge of misleading’ promotions have flooded Instagram and Facebook
https://www.statnews.com/pharmalot/2025/12/17/meta-facebook-instagram-weight-obesity-drugs-ads/
By Ed SilvermanDec. 17, 2025
Pharmalot Columnist, Senior Writer
FDA approves brain tumor warning on Depo-Provera label as court battle grows over side effects
‘This is a game changer,’ said one attorney about the impact on Pfizer’s legal arguments
https://www.statnews.com/pharmalot/2025/12/17/fda-pfizer-contraception-cancer-preemption-depoprovera/
By Ed SilvermanDec. 17, 2025
Pharmalot Columnist, Senior Writer
More drugmakers set to sign pricing deals with Trump on Friday
Terms of past deals haven’t been disclosed, leaving their impact uncertain
https://www.statnews.com/2025/12/17/pharma-companies-to-announce-trump-drug-pricing-deals-friday/
By Daniel PayneDec. 17, 2025
Washington Correspondent
Read American Science, Shattered
An eight-decade partnership between universities and the federal government made U.S. science preeminent.
https://www.statnews.com/american-science-shattered/
Sickle-cell disease associated with early onset of clonal hematopoiesis, a precancerous condition
https://www.statnews.com/sponsor/2025/12/15/sickle-cell-disease-associated-with-early-onset-of-clonal-hematopoiesis-a-precancerous-condition/
The discovery, led by researchers at Dana-Farber, could pave the way for interventions to reduce the risk of blood cancers among people with sickle-cell disease.
Hospitals owned by real estate investors more likely to close or go bankrupt New research probes what happens when health care systems sell their land to financial firms
https://www.statnews.com/2025/12/18/hospitals-acquired-reits-more-likely-close-go-bankrupt/
By Tara BannowDec. 18, 2025
Hospitals and Insurance Reporter
New York Giants team doctor: Clinics offering ‘miracle injections,’ ‘next generation cell therapies’ are selling false hope We must separate the science from the sales pitch in regenerative medicine
https://www.statnews.com/2025/12/18/regenerative-medicine-stem-cells-miracles-giants/
By Scott RodeoDec. 18, 2025
Rodeo is an attending surgeon and vice chair of orthopedic research at the Hospital for Special Surgery and head team physician for the New York Giants.
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