The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

RA/QA News Roll: Mid October 2025

Here's what's happening at FDA and across the broader life science RA/QA space.

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The FDA Group
Oct 17, 2025
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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


  • Government shutdown continues with no end in sight — We’re now weeks into the government shutdown. Republican and Democratic legislators both appear to be even more entrenched in their respective positions than they were a week ago. The White House has begun firing federal employees at agencies perceived to have Democratic leanings (FDA appears to be exempt so far), resulting in Democratic legislators appearing less likely to believe their Republican counterparts would negotiate in good faith.

  • Makary’s efforts spare the FDA from the latest round of RIFs — According to reporting by the nonprofit news organization NOTUS, the FDA was not among the HHS divisions that saw RIFs after the government shutdown. Commissioner Martin Makary had informed staff that he had struck a deal with the White House to exempt the agency from further reductions in force that other HHS divisions were expected to be subject to.

  • Generic mifepristone approval triggers political backlash 💊 — The FDA approved a third generic version of the abortion drug mifepristone made by Evita Solutions, leading to major political pushback. Sen. Josh Hawley (R-Mo.) wrote that he has “lost confidence in the leadership at FDA” and called for the decision to be reversed. Students for Life America called the approval “a stain on the Trump Presidency and another sign that the deep state at the FDA must go.” The approval had been under review since Oct. 1, 2021 — an unusually long four-year review period.

  • Legislators call for CDER leadership firings 💊 — A group of a dozen Republican lawmakers called on Makary to subject two FDA officials — George Tidmarsh, the director of CDER, and Iilun Murphy, the director of CDER’s Office of Generic Drugs — to a reduction-in-force action. “It is clear that rogue actors within the FDA are working to undermine both the sanctity of life and the Administration’s commitment to protecting it,” the legislators wrote.

  • HHS Deputy calls for vaccine changes 💊 — Jim O’Neill, serving as both HHS deputy secretary and acting CDC director, wrote: “I call on vaccine manufacturers to develop safe monovalent vaccines to replace the combined MMR and ‘break up the MMR shot into three totally separate shots,’” quoting an earlier message from President Trump. Any changes to the vaccine would likely take years and significant clinical testing by companies.

FDA General


  • AI assessment concerns mount — Multiple officials told STAT that staff have been asked to identify links between SSRIs, violent behavior, and other adverse events. “When leaders ask staff to go on a data-finding mission, there’s rarely clarity on what will be done with that information, or how it will be presented,” the report noted.

  • FDA reportedly examining aluminum salts in vaccines 💊 — The New York Times reports that the FDA is currently “examining the feasibility of taking aluminum salts out of vaccines, a prospect that vaccine experts said would wipe out about half of the nation’s supply of childhood inoculations and affect shots that protect against whooping cough, polio and deadly flu.”

  • CBER leadership restructure announced 💊 — Center for Biologics Evaluation and Research Director Vinay Prasad emailed staff announcing new leadership structure. Katherine Szarama and Sonday Kelly will serve as acting deputy directors. Scott Steele shifts to the Office of the Chief Medical Officer to “spearhead pandemic preparedness.” Brittany Goldberg becomes chief medical officer of CBER. Sundeep Agrawal becomes CBER’s branch chief of oncology.

  • Orphan Drug Office Director removed 💊 — Endpoints News reports that Sandra Retzky, the director of the FDA’s Office of Orphan Product Development since 2021, has been removed from the position and reassigned. The role is critical for rare disease drug development and comes just as the FDA is preparing to unveil a new “plausible mechanism” pathway.

  • Platform Technology Designation awarded to Krystal Biotech 💊 — The FDA awarded Krystal Biotech the second-ever Platform Technology Designation for its HSV-1 Viral Vector. This designation is intended to accelerate subsequent applications for approval leveraging already-characterized technology platforms.

  • New biosimilars guidance heads to White House review 💊 — The White House is reviewing a draft FDA guidance on “scientific considerations in demonstrating biosimilarity to a reference product” using “comparative clinical studies.” Some groups have asked the FDA to make it easier for comparative studies using non-U.S. comparators.

  • VRBPAC meeting proceeds despite shutdown 💊 — The FDA’s Vaccines and Related Biological Products Advisory Committee met virtually despite the shutdown to make recommendations regarding strain selection for flu vaccines for the 2026 Southern Hemisphere season and the FDA’s allergen sensitization program. You can watch the meeting recording on YouTube here.

  • New approvals announced 💊 — FDA approved Regeneron’s Libtayo for adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation under the Real-Time Oncology Review pilot program. Boehringer Ingelheim’s Jascayd (nerandomilast) was approved as the first new treatment in more than a decade for idiopathic pulmonary fibrosis. Rocket Pharmaceuticals announced the FDA accepted its resubmitted application for Kresladi, a gene therapy for leukocyte adhesion deficiency-I, with a March 28 review goal date.

  • New at-home HIV test cleared 💉 — FDA approved bioLytical Laboratories’ INSTI HIV Self Test for over-the-counter consumer use as an aid in diagnosis of HIV-1 and HIV-2 infection, intended for self-testing by users 18 years or older using fingerstick whole blood.

  • Roche Alzheimer’s test receives clearance 💉 — Roche Diagnostics announced FDA cleared its Elecsys pTau181 test, a blood-based biomarker for initial assessment of Alzheimer’s disease and cognitive decline in primary-care settings.

Compliance and Enforcement


  • FDA issues warning about radiofrequency microneedling devices 💉 — The FDA issued a safety communication warning patients and providers about serious complications associated with certain uses of radiofrequency microneedling devices, including burns, scarring, fat loss, disfigurement, nerve damage and the need for medical intervention.

  • Water testing concerns flagged in Warning Letter 💊 — An FDA Warning Letter to a Texas-based manufacturer cites alleged issues with sterile water procedures. The company’s water system was not adequately validated or maintained, with testing identifying “Enterobacter cloacae (a common fecal microbiota), Burkholderia cepacia, and multiple Pseudomonas sp.”

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  • FDA reveals five CRLs under review for release 💊 — In a quiet update to its database, the FDA acknowledged the existence of five Complete Response Letters listed as being “under review for release.” The existence of a fifth CRL, received by Vyluma, does not appear to have been previously disclosed. The update indicates greater pre-release transparency that could have implications for even private manufacturers.

  • Unauthorized laser therapy devices flagged in Warning Letter 💉 — A recent FDA Warning Letter highlights the marketing of high-powered laser systems without required premarket clearance or approval. The agency also cited quality system violations and failure to maintain design controls.

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