RA/QA News Roll: Late October 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
CDER Director Tidmarsh placed on leave, offers resignation 💊 — George Tidmarsh, director of the Center for Drug Evaluation and Research, was placed on administrative leave on Friday by Commissioner Martin Makary after an investigation was opened into LinkedIn posts regarding surrogate endpoint scrutiny. The posts specifically named Aurinia Pharmaceuticals’ Lupkynis and exon skipping therapies for Duchenne muscular dystrophy. Tidmarsh offered his resignation, effective Sunday, following allegations of extortion and soliciting bribes related to communications with an investor. Multiple outlets reported the investigation was triggered after complaints and a lawsuit were filed against Tidmarsh.
Tidmarsh criticizes National Priority Voucher program 💊 — In exit interviews, Tidmarsh expressed significant concerns about the Commissioner’s National Priority Voucher program, telling The New York Times it could lead to drug approval decisions based on political factors rather than scientific ones. He called the initial voucher meeting a “total mess” that was “shrouded in secrecy and paranoia.” The program features “tumor board”-style review meetings where final approval decisions would be made.
Prasad accused of creating toxic work environment 💊 — Outgoing CDER Director Tidmarsh also shared troubling details about CBER Director Vinay Prasad’s leadership style, including an alleged threat against Deputy Center Director Mike Davis. According to STAT, Prasad wrote: “If you continue to choose not to do what I tell you. I will spend all of my political capital gets [sic] you fired.” Prasad has reportedly blocked transfers out of CBER and multiple employees have filed HR complaints about his management. More in Endpoints and ABC News.
FDA awards first National Priority Vouchers 💊 — The agency announced nine recipients of its inaugural Commissioner’s National Priority Vouchers during a White House event on infertility, exceeding the initially planned five vouchers. Recipients include EMD Serono (fertility drug Pergoveris), Sanofi, Achieve Life Sciences, Regeneron, Dompé, Revolution Medicines, Disc Medicine, Phlow Corp., and US Antibiotics. Makary said more announcements would come in “weeks.” Some applications submitted months ago could see approval within weeks under the program.
Pay fiasco affects over 10% of FDA staff — HHS timekeeping process changes during the shutdown resulted in more than 10% of FDA staff working on user fee tasks not receiving correct pay. “We are coordinating with HHS and in most instances emergency out-of-cycle pay will be processed,” according to an internal FDA email. Sources indicate the issue may be more widespread than initially reported.
Government shutdown enters second month — The shutdown shows no apparent end in sight, with 3,132 employees working without pay (”excepted” staff), 2,258 employees not retained, and an unknown number of contract workers affected. FDA user fee “carryover” funds that support drug review operations during shutdowns are expected to last only about 10 weeks total, raising concerns about continuity of operations through late November.
FDA General
FDA makes drug filing checklists public 💊 — The agency released internal checklists used to determine whether New Drug and Biologics License Applications are complete and reviewable, aiming to “increase transparency into FDA filing procedures and reduce the prevalence of filing deficiencies.” The checklists are contained in the CDER Manual of Policies and Procedures document MAPP 6025.4, “Good Review Practice: Refuse to File.”
Patient-focused drug development guidance released 💊 — Despite the shutdown, the FDA published guidance on clinical outcome assessments, specifically the selection, development and modification of COAs for patient-focused drug development. COAs measure “how a patient feels or functions” and include patient-reported, observer-reported, and clinician-reported outcomes.
FDA to merge medical product inspectorates 💉💊 — The Office of Inspections and Investigations plans to merge “all its medical product and clinical research inspectorates, turning inspectors into generalists,” reversing a previous reorganization toward specialization. The change, referred to as the “Simple Reform,” is intended to allow OII to handle workload differences across the organization and will be phased in.
FDA approval rate slowing significantly 💊 — RBC Capital Markets analysis found Q3 2025 FDA drug approval rate dropped to 73% from historical average of 87%, rejected applications increased to 15% from 10% average, and deadline delays rose from 4% to 11%. The agency has issued 35 CRLs to drug and biologics sponsors so far this year.
Steep hiring losses at drug centers 💊 — Updated FDA data show extraordinary losses in fiscal year 2025, with CDER experiencing net losses of 1,093 employees and CBER losing 224. Hiring has dramatically stalled, with CDER hiring just 10 new staff in Q3 and Q4, and CBER only five. Without backfilling retirements and departures, both divisions face significant attrition risks.
Biosimilars policy undergoes major shakeup 💊 — FDA announced it will no longer require comparative efficacy studies (CES) for most biosimilars, stating that comparative analytical assessments are “generally more sensitive than a CES to detect differences between two products.” The agency also designated several biosimilar versions of Prolia and Xgeva as interchangeable, signaling rapid implementation of the new policy. Final guidance eliminating switching study requirements is expected within three to six months.
Expanded access guidance finally published 💊 — FDA released an updated final guidance on its expanded access (”compassionate use”) program, last updated in June 2016. The guidance answers common questions about eligibility and program operations for patients otherwise ineligible for clinical trials who may request access to investigational drugs.