Health Care Week in Review | Government Shutdown Ends; FDA Announces a Warning Label Change for Hormone Replacement Therapy (HRT) Products for Menopause

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news. 

Regulations, Notices & Guidance

• On November 14, 2025, the Food and Drug Administration (FDA) released guidance entitled, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use. This guidance is intended to assist abbreviated new drug application (ANDA) applicants that reference a drug product intended for parenteral, ophthalmic, or otic use in seeking approval of a drug that is qualitatively (Q1) different or quantitatively (Q2) different from the reference listed drug (RLD) with respect to the pH adjuster(s). This guidance describes how FDA intends to evaluate a request for a waiver of agency requirements for a Q1 or Q2 difference in pH adjuster, including recommendations on the type of information to provide in support of such a waiver request. This guidance finalizes the draft guidance of the same title issued on April 14, 2022.
• On November 14, 2025, FDA released guidance entitled, Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers. The guidance addresses frequently asked questions, including those related to the implementation of FDA’s regulations on expanded access to investigational drugs and other topics related to expanded access that are promulgated through the 21st Century Cures Act (Cures Act) and the FDA Reauthorization Act of 2017 (FDARA).
• On November 14, 2025, FDA released draft guidance entitled, Menstrual Products - Performance Testing and Labeling Recommendations. This draft guidance document provides recommendations for performance testing, labeling, and information for inclusion in premarket notification (510(k)) submissions, when necessary, for certain menstrual products. The recommendations in this guidance apply to tampons, pads, and menstrual cups used to absorb or collect menstrual fluid or other vaginal discharge. The recommendations reflect updated review practices and are intended to promote consistency and transparency in product labeling and testing for manufacturers of these devices.
• On November 14, 2025, FDA released draft guidance entitled, Quality Management System Information for Certain Premarket Submission Reviews. FDA amended the medical device current good manufacturing practice (CGMP) requirements, previously in the quality system regulation (QS regulation) and now the quality management system regulation (QMSR), effective February 2, 2026. These amendments align more closely with the international consensus standard for devices by incorporating by reference an international standard specific for device quality management systems. This draft guidance document is intended to assist FDA staff and medical device manufacturers in understanding FDA expectations about preparing and maintaining a Quality Management System (QMS) and providing the information required to be included in certain marketing submissions regarding a QMS, in line with the QMSR.  

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event. 

• November 16-18, 2025: The National Institutes of Health (NIH) announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting with some sessions open to the public.
• December 1, 2025: NIH announced a peer review meeting of the draft National Toxicology Program (NTP) Developmental and Reproductive Toxicity Technical Report on 2-Hydroxy-4-methoxybenzophenone. This is a hybrid meeting open to the public.
• December 1, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• December 3, 2025: FDA announced a meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• December 4, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. This is a hybrid meeting with some sessions open to the public.
• December 4-5, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of the National Advisory Council on Nurse Education and Practice. This is a hybrid meeting open to the public.
• December 5, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• **December 5, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Committee on Immunization Practices. This is a hybrid meeting open to the public.
• December 10, 2025: The Centers for Medicare & Medicaid Services (CMS) announced a town hall meeting on fiscal year (FY) 2027 applications for new technology add-on payments. This is a virtual meeting open to the public.
• December 10, 2025: FDA announced a workshop entitled, Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks. This is a hybrid meeting open to the public.
• January 23, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a virtual meeting open to the public.
• January 26-27, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a virtual meeting with some sessions open to the public.
• February 9-10, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• March 30-31, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• May 4, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• June 1-2, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• June 5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

• On November 14, 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report entitled, The National Institutes of Health Needs to Improve the Cybersecurity of the All of Us Research Program to Protect Participant Data. OIG undertook an audit of the NIH All of Us Research Program, which aims to accelerate disease prevention and treatment by collecting available health data from over a million volunteer participants. OIG found that while the program’s Data and Research Center (DRC) had implemented some cybersecurity measures, NIH did not adequately ensure that key safeguards were in place to protect participant data. The audit concluded that NIH did not verify that user access to sensitive research data was appropriately restricted, did not communicate national security concerns related to genomic data to its awardee, and did not ensure that identified security and privacy weaknesses were fixed within required federal timeframes. OIG issued five recommendations directing NIH to strengthen access controls, prohibit improper downloading of participant data, address national security risks by updating security requirements and system categorization, and align remediation timelines with federal standards. NIH agreed to implement all five recommendations.
• On November 13, 2025, KFF released a report entitled, Mapping the Uneven Burden of Rising ACA Marketplace Premium Payments due to Enhanced Tax Credit Expiration. The report examines how the planned expiration of enhanced premium tax credits (EPTCs) under the American Rescue Plan Act (ARPA) and the Inflation Reduction Act (IRA) will affect premium payments for individuals purchasing benchmark “silver” plans through the Affordable Care Act (ACA) Marketplace. Using modeled scenarios for different ages, income levels, and states, KFF found that premium payments would rise substantially for millions of people, with the steepest increases falling on older adults with incomes just above 400 percent of the federal poverty level (FPL). KFF found that while lower-income enrollees would still receive some assistance, they would still face notable increases. However, the impact is far more uneven and severe for middle-income individuals in high-premium states, where annual costs for a 60-year-old individual could increase by tens of thousands of dollars. The analysis emphasizes that these estimates reflect a “what-if” scenario based on average benchmark premiums and constant enrollee characteristics, but it underscores the potential for significant affordability challenges and state-by-state variation if EPTCs are allowed to lapse.

Other Health Policy News

• On November 12, 2025, the government shutdown ended when President Trump signed H.R. 5371, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026.
  
  Earlier that day, the House of Representatives voted 222 to 209 to fund most of the government via a continuing resolution (CR) through January 30, 2026. Of note, the legislation included full fiscal year (FY) 2026 funding for three appropriations bills: Agriculture-FDA, Military Construction-VA, and Legislative Branch. On November 9, 2025, Senate Republicans and eight Senate Democrats voted to pass the bill, by a vote of 60-40.
  
  The bill extends several public health provisions through January 30, 2026, retroactive to the start of the shutdown on October 1, 2025. These provisions include an extension of Medicare telehealth flexibilities and funding for community health centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education (THCGME) program. The CR also waives the requirement for “PAYGO” sequestration, which would have triggered a four percent cut to Medicare provider payments starting in 2026 if not addressed.
  
  The CR does not include an extension of EPTCs for ACA Marketplace plans, which remain set to expire on December 31, 2025, unless an extension is enacted. Senate Majority Leader John Thune has pledged to allow a vote on an EPTC extension proposal by mid-December.
  
  The full text of the CR can be found here. A section by section of the CR can be found here.
• On November 10, 2025, FDA announced that the agency will initiate the removal of broad “black box” warnings from hormone replacement therapy (HRT) products used to address the symptoms of menopause. The decision follows an internal review led by FDA Commissioner Martin Makary, who convened an expert panel in July 2025 to examine the issue. Commissioner Makary has publicly argued that the prior warnings, first introduced in 2003, created a “fear machine” that deterred millions of women from a potentially beneficial treatment. Commissioner Makary and other senior FDA officials contend that evidence now supports a more nuanced approach. Under the revised guidance, product labeling will no longer include boxed warnings linking HRT to cardiovascular disease, breast cancer, and probable dementia. However, a boxed warning will remain on systemic estrogen-alone products concerning endometrial cancer risk. The updated labeling will also recommend initiating HRT within 10 years of menopause onset or before age 60.
  
  A press release can be found here. A fact sheet can be found here.

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