RA/QA News Roll: Mid September 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 and the New Administration
Vaccine advisory committee sees key departure 💊 — The agency has removed Paul Offit from its Vaccines and Related Biological Products Advisory Committee ahead of his scheduled term expiration in January 2027. Offit has been a prominent vaccine advocate and frequent critic of HHS Secretary Robert F. Kennedy Jr.'s positions on immunizations.
Sweeping changes to vaccine co-administration policies 💊 — CBER has implemented new restrictions on how vaccines can be labeled for simultaneous administration with other immunizations. Director Vinay Prasad issued a memo stating that previous approvals based on small studies showing comparable antibody responses are insufficient, as the agency questions whether such immune markers translate to actual clinical protection. Future approvals for co-administration claims will require large pragmatic trials with clinical endpoints like symptomatic infection rates rather than just immunological measures.
President calls for transparency on COVID therapeutics 💊 — President Trump used his social media platform to demand that pharmaceutical companies publicly release efficacy data for COVID-19 treatments and vaccines that they have privately shared with his administration. The president expressed frustration that companies show impressive results to government officials but withhold this information from the CDC and the public.
CBER director faces criticism over content removal efforts 💊 — Vinay Prasad has pursued copyright claims to remove YouTube videos featuring his public statements, according to media reports. The takedown requests targeted content compiled by a physician-critic who had documented various remarks made by health officials in the current administration.
FDA General
Digital infrastructure changes hamper document access — We’ve noticed that the FDA’s website has been modified to force users to download most regulatory documents as standalone files rather than viewing them directly through web browsers. This shift has complicated information sharing, reduced search engine indexing, and made it more difficult for stakeholders to reference specific regulatory guidance and policies.
Regulatory development agenda shows continuity with previous administration — The Trump administration's Spring 2025 Unified Agenda reveals that the FDA's planned regulations largely mirror the Biden-era pipeline, with approximately a dozen previous initiatives removed but minimal new rulemaking projects added to the development schedule.
CDER leadership signals advisory committee restructuring 💊 — Center director George Tidmarsh reportedly announced intentions to reduce reliance on product-specific advisory committee meetings for drug approval decisions. The agency plans to redirect these expert panels toward addressing broader regulatory policy questions rather than evaluating individual applications, citing efficiency concerns and arguing that public release of complete response letters provides equivalent transparency.
Agency developing prescription-to-OTC transition strategy 💊 — CDER is reportedly preparing to solicit industry input on converting prescription medications to over-the-counter status. Director Tidmarsh indicated the agency will issue Federal Register notices seeking information about the societal benefits of such switches, signaling a proactive approach to expanding non-prescription drug access.
Planned release of pediatric vaccine safety analysis 💊 — Commissioner Makary disclosed in television interviews that the agency is conducting investigations into COVID-19 vaccine-related deaths in children, including family interviews and autopsy reviews. The resulting report, expected to document 25 childhood fatalities linked to coronavirus vaccines according to media reports, will be presented at an upcoming CDC advisory committee meeting.
Previously confidential rejection letters made accessible 💊 — The agency has published redacted versions of 89 recent Complete Response Letters for unapproved products, marking a significant transparency initiative. These documents provide unprecedented insight into the FDA's rationale for rejecting drug applications, with Commissioner Makary committing to ongoing publication of such letters. We analyzed them to pull out key themes:
New framework proposed for ultra-rare disease approvals 💊 — The FDA introduced Rare Disease Evidence Principles intended to streamline approvals for conditions affecting fewer than 1,000 Americans with known genetic drivers. However, a recent analysis suggests these principles largely formalize existing practices, as most recent rare disease approvals already relied on single pivotal trials plus confirmatory evidence.
