RA/QA News Roll: Mid August 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Just a quick note that in case you’ve missed our recent FDA-specific news posts, we’ve been gathering the recent flurry of agency news in more focused newsrolls. You can view them all here.
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
Sean Keveney named FDA Chief Counsel — The FDA announced the selection of Sean Keveney as FDA chief counsel after several months of delays in filling this critical position. Keveney was most recently acting general counsel of HHS and has shown a willingness to fight the Trump administration's toughest political battles, including litigating against major universities for alleged violations of Title VI of the Civil Rights Act. This could signal an adversarial approach against perceived opponents and active engagement on political hot topics like mifepristone.
New executive order restricts federal grants — President Trump signed an executive order requiring all federal grants to undergo pre-issuance review to ensure consistency "with applicable law, agency priorities, and the national interest." The FDA "shall not issue any new funding opportunity announcements" until new procedures are implemented, and "discretionary awards must, where applicable, demonstrably advance the President's policy priorities."
Prasad returns to CBER leadership 💊 — In an extraordinary turn of events, Vinay Prasad has returned as director of the Center for Biologics Evaluation and Research less than two weeks after resigning under political pressure. The resignation had reportedly been ordered by White House Chief of Staff Susie Wiles following a campaign by conservative activist Laura Loomer, but FDA Commissioner Martin Makary successfully advocated for Prasad's return despite significant political risks.
MAHA report delayed over quality concerns — The much-anticipated second Make America Healthy Again Commission report was delayed as the White House took time to review it, referencing errors in the commission's earlier report.
FDA General
FDA onshoring initiatives launched 💊 — The FDA announced creation of a new docket to collect public comment on "accelerating the establishment of new pharmaceutical manufacturing facilities in the United States" and plans a Sept. 30 public meeting to present a "draft framework" on onshoring. The agency also launched a new "PreCheck Program" using a two-phase approach: the Facility Readiness Phase provides more frequent communication regarding facility design and construction, while the Application Submission Phase focuses on streamlining Chemistry, Manufacturing, and Controls sections through pre-application meetings.
FDA "Gold Standard Science" policy implemented — The FDA released a new Staff Manual Guide titled "Gold Standard Science at FDA" in response to President Trump's executive order on "Restoring Gold Standard Science." The 21-page document emphasizes reproducible, transparent research and requires FDA communications to use "cautious, evidence-based language" and avoid "speculative claims or extrapolations that extend beyond the data's scope."
Task Force on Safer Childhood Vaccines reconstituted 💊 — HHS announced reinstatement of the disbanded Task Force on Safer Childhood Vaccines to "improve the safety, quality, and oversight of vaccines administered to American children." The task force includes FDA, NIH and CDC membership, with NIH Director Jay Bhattacharya serving as chairman and must develop a formal report to Congress within two years.
Makary announces record device authorizations 💉 — At the Medical Device User Fee program reauthorization meeting, Commissioner Makary expressed strong support for CDRH Director Michelle Tarver and claimed CDRH authorized "120 medical devices" last year, stating "I think that's a record, Michelle. If it's not a record let's just claim it as a record."
Cell and gene therapy meeting reaches capacity 💊 — An upcoming Sept. 18 "public listening meeting" hosted by CBER's Office of Therapeutic Products generated so much interest that the FDA announced registration "is now full," with attendees needing to wait for a recording more than a month before the meeting starts.
June generic drug approval data released 💊 — The FDA published generic drug approval data for June showing 67 approvals, of which nine were first-time generics and 18 were approved during their first review cycle. Another 22 drugs were granted "tentative" approval, while 85 products were given Complete Response Letters—the lowest amount so far this fiscal year.
Pharmaceutical quality report reveals manufacturing trends 💊 — The FDA's Report on the State of Pharmaceutical Quality showed that only 41% of FDA-regulated drug manufacturing sites are located in the U.S., with U.S. sites increasing 7% over five years compared to 27% growth for Chinese sites and 18% for Indian sites. The report also revealed that drug quality assurance inspections still haven't recovered to pre-pandemic levels, with 1,308 inspections in fiscal 2019 versus 972 in fiscal 2024.
Real-world evidence meeting planned 💊 — The FDA announced a Sept. 23 meeting with the Duke-Margolis Institute for Health Policy focused on regulatory submissions containing real-world evidence, where "experts will discuss lessons learned from case studies in which RWE was used for regulatory decision-making for medical products."
Compliance and Enforcement
FDA drug quality practices criticized 💊 — ProPublica published an investigation showing the FDA frequently made exceptions to import alert bans to prevent drug shortages but did not publicize its actions or conduct testing of imported products. The report specifically highlighted Sun Pharma's "grossly inadequate" efforts to fix manufacturing problems, while the FDA "did little to warn the public or stop the drugs from coming to the United States."
FDA warns sterile drug manufacturer over process and quality failures 💊 — The FDA cited a sterile drug manufacturer for serious CGMP violations, including failure to validate and control manufacturing processes, recurring defects such as particulate contamination, and inadequate investigations of sterility and bioburden failures. The agency also flagged weak laboratory controls, insufficient stability testing, and a nonfunctional quality unit that had not performed required oversight or reviews since 2018.