RA/QA News Roll: Mid December 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
FDA Leadership and Administration
Pazdur files retirement paperwork amid leadership tensions 💊 — CDER Director Rick Pazdur submitted paperwork to retire by the end of December, just weeks after accepting the role. Reports indicate concerns about Commissioner Makary and CBER Director Prasad inserting themselves into drug review decisions, and Makary’s efforts to place political appointees in key CDER positions contributed to the decision.
White House and HHS scrutinize Makary’s management — Following multiple leadership crises, including the George Tidmarsh ouster and now Pazdur’s retirement filing, reports indicate White House officials previously considered scaling back Makary’s role by installing a day-to-day operations lead while keeping him as commissioner. HHS Secretary Kennedy had similarly considered sidelining Makary due to management concerns, including his avoidance of email and limited meetings with division directors.
Political interference in drug reviews surfaces — Bloomberg reports that two Republican lawmakers were initially invited to attend an FDA meeting on potential expanded approval of a drug backed by billionaire Patrick Soon-Shiong, though the plan was ultimately scrapped due to internal opposition. Commissioner Makary was reportedly aware of the invitation, raising concerns about political pressure on the traditionally closed regulatory review process.
Tracy Beth Høeg named acting CDER director 💊 — FDA announced Høeg, previously senior advisor to Makary and CBER’s senior clinical science advisor, as acting director of CDER. Makary called her “the right scientist to fully modernize CDER and finish the job of establishing a culture of cross-center coordination,” suggesting the appointment may be permanent. Høeg conducted the controversial analysis, claiming 10 children died from COVID-19 vaccination, and has no prior CDER experience.
OTC drug office leadership ousted 💊 — Theresa Michele, longtime director of CDER’s Office of Nonprescription Drugs, was involuntarily transferred to CDRH after Commissioner Makary reportedly felt the office wasn’t approving enough OTC drugs. Karen Murry, the office’s deputy director, will replace Michele. The change could destabilize ongoing OMUFA implementation and PDUFA reauthorization negotiations.
FDA General
Prasad announces sweeping vaccine regulatory overhaul 💊 — CBER Director Vinay Prasad sent an email detailing plans to fundamentally restructure vaccine regulation following findings that “at least 10 children have died after and because of receiving COVID-19 vaccination.” Changes include requiring pre-market randomized trials with clinical endpoints rather than antibody titers, new requirements for concomitant vaccine administration studies, elimination of surrogate endpoints for pregnant populations, and revised safety labeling. Prasad instructed dissenting staff to submit resignation letters to supervisors.
QMSR technical amendments finalized 💉 — With February 2, 2026, implementation approaching, FDA posted a final rule making 179 technical changes, replacing QSR references with QMSR throughout regulations.
COVID vaccine boxed warning anticipated 💊 — CNN reports FDA intends to add its most serious “black box” warning to COVID vaccines, with announcement expected by year’s end. Former journalist Alex Berenson first reported that the pending warning would highlight purported links to childhood deaths. The FDA previously updated mRNA COVID vaccine labeling in July for myocarditis and pericarditis risks.
First Commissioner’s Priority Voucher approval granted 💊 — U.S. Antibiotics’ Augmentin XR (amoxicillin-clavulanate potassium) became the first product approved under the FDA’s new Commissioner’s National Priority Voucher program. The ultra-rapid review program allows data submission before application filing, with reviews completed in approximately two months. Additional novel product approvals under CNPV are expected in the coming weeks.
Substantial evidence standard shifting to single trials 💊 — Commissioner Makary told STAT the FDA will soon announce requiring only one clinical study as substantial evidence rather than two historically required, making single pivotal trials the default. The change appears redundant as the FDA already approves the majority of novel products using single trials with confirmatory evidence—66% of 2024 novel drug approvals relied on one trial.
Vaccine framework changes detailed 💊 — CBER’s new approach eliminates immunogenicity-based population expansions, requires clinical endpoint trials for pneumonia vaccines, plans complete revision of “evidence-based catastrophe” flu vaccine framework, mandates pragmatic RCTs for concurrent vaccine administration, and emphasizes enforcement of post-market commitments. Guidance documents from OVRR and OBPV are expected soon.
OTC acceleration push announced 💊 — Commissioner Makary told Fox Business FDA plans to “move a lot of medications to over the counter,” including anti-nausea medications and naloxone. Framework for switches: “If it’s safe, if you don’t need to follow your lab studies when you’re on a medication, if there’s no risk of addiction, then it should be over the counter.”
AI deployment expands with agentic capabilities — FDA announced expansion beyond the “Elsa” LLM tool to include new “agentic” AI capabilities for multistep regulatory tasks within a high-security GovCloud environment. A two-month Agentic AI Challenge was launched for staff to build solutions for demonstration at the January 2026 Scientific Computing Day.
New lawsuits target mifepristone access 💊 — Texas and Florida filed suit against the FDA’s September approval of generic mifepristone from Evita Solutions, claiming the 2000 approval was illegal because pregnancy isn’t an illness and the accelerated approval was improper. Missouri, Kansas, and Idaho separately sued over the same generic approval seeking to block distribution and reimpose in-person prescribing.
Bayesian methodology guidance mysteriously delayed 💊 — Despite White House clearance “without change” on November 3, the FDA hasn’t released draft guidance on Bayesian methodology in clinical trials. The month-long delay suggests the document may be held for a larger “seamless clinical trials” package announcement.
TEMPO digital health pilot launches with CMS 💉 — CDRH’s Digital Health Center of Excellence announced the Technology-Enabled Meaningful Patient Outcomes pilot in connection with CMS’s ACCESS model. The program offers enforcement discretion for premarket authorization, allowing real-world data collection for subsequent marketing authorization. The FDA plans to select approximately 10 manufacturers in each of four clinical areas.
Medical gases guidance updated for new regulations 💊 — FDA released revised draft guidance on current good manufacturing practices for designated medical gases (oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, medical air, carbon monoxide), incorporating July 2024 final rule requirements.
Compliance and Enforcement
Toilet bowl cleaner cross-contamination cited 💊 — A Wisconsin hand sanitizer manufacturer received a warning letter for making sanitizing foam “using the same equipment that you use to manufacture non-drug products, including industrial cleaning detergents and disinfectants such as Bowl Cleaner,” violating GMP requirements against cross-contamination risk.
Unapproved biologic marketed as healing tissue matrix 💊 — A firm manufacturing a hypodermis-derived extracellular matrix product marketed to support wound healing and tissue repair received a warning letter for distributing an unapproved new drug and unlicensed biological product, failing to meet criteria for regulation solely under HCT/P regulations, and significant CGMP deficiencies including lack of validated procedures and identity testing.
HCT/P donor screening lapses at fertility tissue provider 💊 — An HCT/P provider received a warning letter after inspection found repeat failures to test reproductive tissue donors for required communicable disease agents (e.g., West Nile Virus), incomplete medical risk screening forms, improper eligibility determinations before test results were received, and failure to anonymize donor records and label HCT/P containers per regulation.
Implantable hearing device quality system violations 💉 — A manufacturer of an implantable auditory device was cited for Quality System Regulation failures, including inadequate complaint handling and investigation processes, ineffective CAPAs for cleanroom issues, and deficiencies in design validation and risk analysis — with delayed or incomplete investigations of serious complaints and systemic QA gaps.
OTC drug CGMP failures 💊 — A drug manufacturer producing over-the-counter liquid products was cited for significant CGMP violations. The quality unit lacked adequate written procedures and routinely released batches before completing required testing for active ingredient strength and microbial results, and failed to maintain complete laboratory test records.
SSRI pregnancy warning petition advances 💊 — STAT reports Tracy Beth Høeg heavily involved in reviewing citizen petition requesting pregnancy warnings for SSRIs. Høeg reportedly refers to petitioner Adam Urato “as a friend” and presented slides summarizing the petition as her own work, raising concerns about objectivity in her new CDER role.
Hemp legislation proposes FDA requirements 💊 — The new Cannabinoid Safety and Regulation Act would require FDA testing for safety and manufacturing standards for hemp-derived products, with authority to recall products containing excessive THC or dangerous additives. Sales would be restricted to ages 21+.
Governing
PDUFA negotiations reveal “America First” proposals 💊 — Meeting minutes show FDA proposing differential user fees (lower for domestic, higher for international facilities), faster reviews for domestic facility supplements, and reduced application fees for U.S.-based Phase 1 trials. Industry is concerned about rising PDUFA costs, seeking to limit FDA staff growth and cap inflation adjustments.
Advisory committee meetings plummet 💊 — The FDA is on pace for only nine drug/biologic advisory committees in 2025 versus over 30 in 2024. With Pazdur’s pending retirement, 2026 totals could drop further as he championed many committees.