RA/QA News Roll: Late August 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
Trump orders agencies to focus on “digital potholes” — A new executive order, America by Design, directs agencies (including the FDA) to improve government websites with high impact on daily life.
Advisory committee conflicts at historic lows despite reform push 💊 — A new study in JAMA found that conflicts of interest among members of the FDA's Vaccines and Related Biological Products Advisory Committee have hovered around historic lows in recent years. The findings come just as FDA Commissioner Makary and HHS Secretary Robert F. Kennedy Jr. have promoted taking further steps intended to reduce supposed conflicts of interest on advisory committees at the FDA and CDC. However, Makary has also been favoring consultant meetings instead of formal advisory committees, which are not held to the same standards of ethical disclosures or compliance as traditional advisory committees.
Makary interview with Lara Trump — FDA Commissioner Makary participated in an interview with Fox News' Lara Trump that aired over the weekend at 9 PM ET, according to promotion by Trump and the FDA.
FDA transformation in context compared to CDC upheaval — FDA staff may be taking some comfort in the thought that "at least we're not the CDC," following major turbulence at the Centers for Disease Control and Prevention and resignations-in-solidarity of several top CDC leaders. While the FDA has gone through turbulent changes in recent months, Commissioner Makary and other top FDA executives appear to have managed to walk the fine line between keeping HHS Secretary Kennedy satisfied while avoiding mass resignations of FDA staff. However, this dynamic remains delicate and could change quickly, particularly if the FDA were to take action on products like mifepristone.
FDA General
Two new oncology guidances released 💊 — The FDA finalized draft guidances on (1) use of overall survival as an endpoint in oncology trials, and (2) dose optimization for therapeutic radiopharmaceuticals.
FDA updates PCCP guidance 💉 — The agency removed Biden-era AI policy references from its guidance on Predetermined Change Control Plans for AI/ML medical devices.
FDA CMC Development and Readiness Pilot, Year 4 💊 — FDA announced continuation of its pilot to accelerate CMC readiness for expedited products; applications open Oct. 1.
CDRH website updates lagging behind social media presence 💉 — The FDA's public website has undergone stark changes since the start of the Trump administration, but one area that has started to return to normal is the agency's use of its "what's new" pages to detail what its main review centers are up to. While CDER and CBER webpages are both generally updated on a daily basis now, the same page for CDRH has not been updated despite the fact that CDRH's social media account regularly publicizes information on new meetings and device-specific warnings. The disconnect raises questions about why CDRH is able to publish social media posts but not publish those same updates on its own website.
Measuring staff departures at FDA — ProPublica analysis found the FDA has lost a significant number of staff since the start of the Trump administration, including more than 400 workers who support inspections and 240 consumer safety specialists. CBER and CDRH are down by more than 20%, CDER by 20%, and the Office of the Commissioner by 26%. The Office of Inspections and Investigations has been the least impacted at 16%.
New standards-of-conduct regulation for HHS staff — HHS published a final rule updating standards of conduct for its workforce, eliminating supplementary FDA-specific provisions (45 CFR 73a) deemed obsolete or superseded.
USAJobs resume restrictions create scientific hiring challenge — The federal government's main hiring portal, USAJobs, is implementing new restrictions that go into effect in late September 2025, which could significantly complicate the FDA's recruitment of scientific talent. Specifically, resumes submitted to USAJobs.gov will be limited to a maximum of 2 pages. This poses a major challenge for the FDA because there is a stark difference between resumes submitted by people with scientific backgrounds and those without—while most resumes for non-scientific roles are one or two pages, many resumes for accomplished scientists can be dozens of pages long, consisting of a curriculum vitae summing up a career of activities. The restriction could force the FDA to identify scientific talent through alternative channels or hire more scientists using the 21st Century Cures Act hiring authorities.
FDA approves Covid-19 vaccines for 2025-26 season 💊 — FDA approved updated formulations from Pfizer (ages 5+ at risk, 65+ unrestricted), Moderna (ages 6 months+ at risk, 65+ unrestricted), and Novavax (ages 12+ at risk, 65+ unrestricted). EUAs will be revoked.
DSCSA deadlines arrive 💊 — Wholesale distributors had to comply with enhanced drug traceability requirements by Aug. 27. Pharmacies (with ≥26 employees) face their deadline Nov. 27.
Updated MDUFA small business form released 💉 — The FDA refreshed Form 3602N for small device manufacturers seeking reduced user fees.
FDA launches adverse event public dashboard 💊 — The FDA will now publish FAERS adverse event data in near real time via its public dashboard, instead of on a multi-month delay. Commissioner Makary has tied this to his broader goal of consolidating the agency’s 10 disparate adverse event systems into a unified, AI-enabled platform.
FDA effort to reduce CGT clinical holds 💊 — CBER’s Office of Therapeutic Products cut IND clinical holds from 14.5% to 8.2% by proactively flagging and resolving issues during review.
FDA schedules patch test workshop 💉 — A public meeting on Oct. 23 will address approval pathways for new allergens in patch testing.
Compliance and Enforcement
Not-approvable letter issued for VenoValve device 💉 — EnVVeno Medical announced that the FDA issued a "not-approvable letter" for its application to approve the VenoValve device, which is intended to treat severe deep chronic venous insufficiency. The regulatory setback represents a significant hurdle for the company's cardiovascular device development program.
Warning letter to a foreign spirometer manufacturer 💉 — FDA cites marketing of a spirometry device without required premarket clearance/approval and multiple QSR lapses, including missing software design validation, weak CAPA, unvalidated cleaning/disinfection, poor control of nonconforming product, inadequate complaint handling (incl. MDR evaluation), and servicing not tied to complaints.