RA/QA News Roll: Late November 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
Makary-Kennedy power struggle intensifies — POLITICO reports FDA Commissioner Martin Makary and HHS Secretary Robert F. Kennedy Jr. are locked in a “power struggle” over vaccine safety studies and agency staffing. Kennedy requested expedited vaccine safety studies, but Makary hasn’t acted, believing the agency first needs a new system for examining vaccine side effects. HHS is now closely monitoring FDA operations, including schedules and planned announcements, with the White House frequently intervening in disputes between the two leaders.
White House considered sidelining Makary — The Wall Street Journal reveals HHS Secretary Kennedy seriously considered installing new leadership to manage the FDA’s day-to-day operations following the George Tidmarsh ouster, which would have left Commissioner Makary as a figurehead. The plan was reportedly dropped after White House Chief of Staff Susie Wiles intervened, though concerns persist about Makary’s management style, including his avoidance of email and limited meetings with division directors.
Deputy chief of staff controversy — Sanjula Jain-Nagpal, a frequent participant in Makary’s “FDA Direct” episodes, introduced herself as “deputy chief of staff” without White House approval. The White House initially called for her resignation, but Makary successfully argued she hadn’t been informed of their objections. She will remain at the FDA but cannot use the deputy chief of staff title, which belongs to Samuel Doran, according to HHS records.
FDA announces major hiring initiative — Commissioner Makary told Bloomberg the agency plans to hire nearly 1,000 new scientists and inspectors over the coming months to support “aggressive plans” for reform. However, the impact will be limited in the near term due to extensive training requirements and the previous termination of staff college members responsible for onboarding new employees.
New HHS leadership appointments — HHS announced several appointments with direct FDA impact: Brian Christine as assistant secretary for health, Michael Stuart as general counsel, and Alicia Jackson as director of the Advanced Research Projects Agency for Health. Christine will lead the upcoming testosterone replacement therapy expert panel scheduled for December 10.
FDA General
Commissioner’s National Priority Voucher program comes under fire 💊 — Congressional Democrats Bernie Sanders and Frank Pallone sent a letter to Commissioner Makary raising concerns that the FDA’s CNPV program has “self-selected such broad and expanding priorities” that any drug could receive a voucher. CDER Director Rick Pazdur privately raised concerns about the program’s legality and pace, arguing it could threaten patient safety. STAT News reports review panels consist of political appointees and executives rather than career scientific reviewers, with the FDA yet to publish a staff manual detailing how the program operates.
Prasad overhauls CBER research priorities 💊 — CBER Director Vinay Prasad announced sweeping changes to the center’s regulatory science approach, requiring his approval for ongoing research submissions and criticizing studies that “hide or shield safety signals.” Prasad emphasized taxpayer accountability, stating some FDA research furthers industry interests rather than regulatory missions, and plans to meet with each laboratory principal investigator to ensure alignment with the FDA’s mission.
Pazdur raises concerns about reduced study requirements 💊 — The new CDER director has privately expressed concerns about Commissioner Makary’s plans to reduce the number of research studies needed for drug-related decisions like label changes, according to The Washington Post. While Pazdur’s Oncology Center of Excellence allows single-trial approaches, these come with significant requirements for adequate, well-controlled studies with confirmatory evidence.
Expert panel replaces advisory committee for testosterone therapy 💊 — The FDA scheduled a December 10 expert panel on testosterone replacement therapy for men, led by HHS Assistant Secretary Brian Christine. Commissioner Makary’s preference for expert panels over traditional advisory committees marks a shift in the FDA’s approach to external input, though the format, agenda, and attending experts remain unannounced.
Novartis gene therapy approved for older SMA patients 💊 — The FDA approved Itvisma (onasemnogene abeparvovec-brve), the first gene replacement therapy for spinal muscular atrophy patients over age 2. The one-time therapy replaces the SMN1 gene to address the root cause of SMA, expanding treatment options beyond the previously approved Zolgensma limited to younger patients.
Zantac returns with stringent storage requirements 💊 — The FDA approved VKT Pharma’s reformulated ranitidine tablets (150mg and 300mg) following widespread NDMA-related recalls. The approval includes extensive storage conditions: discard after 90 days of opening and maintain dryness with desiccant to prevent impurity formation.
FDA and EMA develop joint AI principles 💊 — Anindita “Annie” Saha, CDER’s new AI and data science policy leader, will present at an EMA workshop on “Opportunities for international convergence.” This marks the FDA’s first AI collaboration with EMA specifically on medicines, following previous partnerships with the UK’s MHRA on machine learning practices and AI-enabled device transparency.