RA/QA News Roll: Late April 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. We’ll try our best not to repeat ourselves in these standard newsrolls, so be sure to check the other posts for a deeper look at what’s happening at the FDA.
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.
If you haven’t upgraded to a paid subscription yet, you can do so here. Also, make sure to follow us on LinkedIn and catch the latest episodes of our podcast, The Life Science Rundown.
Also, it appears that former FDA Commissioner Robert Califf has launched a new blog here on Substack, which will cover "timely topics in biomedicine and research, as well as address enduring issues at the intersection of biomedicine and government."
Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
Also, a quick note: we’ve changed the format slightly to include short titles for each item we link to, so these newsrolls are a bit more scannable.
FDA and the New Administration
Makary distances himself from staff cuts — FDA Commissioner Martin Makary has repeatedly emphasized that he wasn't personally responsible for terminating FDA staff. "I came in after the reductions in force, to make sure that no scientist, or critical staff to that scientist, was laid off," he told CBS News. Though Makary was confirmed a week before the RIF implementation, he's working to separate himself from these controversial decisions.
O'Neill nomination hearing scheduled — The Senate Finance Committee will review Jim O'Neill's nomination for HHS Deputy Secretary on Tuesday, May 6. O'Neill's extensive background on FDA-related issues suggests he could wield significant influence over agency policies if confirmed.
FDA maintains paperwork notices despite restrictions — While new regulatory budgets have limited substantive Federal Register publications, the FDA released 16 Paperwork Reduction Act notices, including research extensions on drug compounding by outsourcing facilities.
Taylor appointed as new FDA CIO — Craig Taylor has been named the FDA's new Chief Information Officer, replacing the recently departed Vid Desai. Taylor brings insider knowledge to the role, having served as the agency's chief information security officer since 2015.
HCT/P guidance documents cleared for release — The White House regulatory affairs office has authorized two FDA guidance documents addressing prevention of tuberculosis and sepsis transmission in human cells, tissues and cellular tissue-based products. These recommendations may offer industry additional implementation time beyond the current May 4 compliance deadline.
Makary confirms political appointee involvement in vaccine reviews — Commissioner Makary acknowledged that his special assistant Tracy Beth Høeg, who lacks FDA review experience, is participating in the Novavax Covid-19 vaccine evaluation. Makary noted vaccine hesitancy concerns, stating: "Eighty-five percent of American health care workers said 'no' to the last Covid booster, so we have a bit of a public trust problem." Høeg has also joined the CDC's Advisory Committee on Immunization Practices as the FDA representative.
Contractors to replace terminated logistics staff — The FDA is developing plans to use contractors to handle responsibilities previously managed by over 50 laid-off employees who coordinated travel arrangements and financial oversight for agency inspectors. Commissioner Makary has reportedly supported this approach.
Kennedy pledges FOIA office restoration — When questioned about the reduction of Freedom of Information Act offices, HHS Secretary Kennedy stated his department is "restoring all the FOIA offices" and developing a more transparent information sharing approach, including a new website cataloging previous FOIA requests and responses.
Reviewer exodus to industry accelerates — STAT News reports growing numbers of FDA reviewers are pursuing private sector positions, with recent workforce reductions ironically fueling the regulatory-to-industry migration that Secretary Kennedy has frequently criticized.
Agency headcount estimated at 15,000 — FDA Matters' Steven Grossman calculates approximately 15,000 employees remain at the FDA after accounting for RIFs, retirements and other departures, though he acknowledges significant data gaps in contractor counts and other variables.
Former officials critique transparency claims — A Washington Post op-ed by former FDA leaders Peter Lurie, Joshua Sharfstein and Aaron Kesselheim argues that despite Secretary Kennedy's transparency promises, many HHS actions have produced precisely the opposite effect.
FDA General
Kluetz departs for industry position — Paul Kluetz, who recently served as deputy director of FDA's Oncology Center of Excellence, has accepted the chief medical officer position at Paradigm Health after nearly 15 years with the agency.
CDER seeks volunteer help for contracting work 💊 — Bloomberg reports that the FDA's Center for Drug Evaluation and Research has requested staff volunteers to assist with contract and acquisition tasks following the layoff of employees previously handling these responsibilities.
Semaglutide compounding decision delayed 💊 — CDER has extended its timeline for responding to Covington & Burling's petition submitted on behalf of Novo Nordisk requesting exclusion of semaglutide from bulk compounding by outsourcing facilities. Acting Director Jacqueline Corrigan-Curay cited "complex issues requiring extensive review and analysis" for missing the statutory response deadline.
Novavax vaccine path clarified 💊 — Following the FDA's unexpected decision not to approve its Covid-19 vaccine, Novavax has received a request for additional clinical data as part of a postmarketing commitment rather than a more demanding postmarketing requirement. The company maintains its application "is approvable" based on FDA discussions. POLITICO also reports that Secretary Kennedy is considering removing COVID-19 vaccines from the CDC's recommended childhood vaccine schedule.
Legal victory for Novo Nordisk 💊 — STAT News reports Novo Nordisk secured a significant legal victory when a judge denied "a compounding trade group's request for a preliminary injunction that would have prevented the FDA from taking action against its members for making copies of semaglutide."
Device quality system transition on schedule 💉 — FDA officials confirmed at the MedCon conference that the February 2026 target for transitioning from the Quality System Regulation to the Quality Management System Regulation remains in effect. CDRH Associate Director Keisha Thomas encouraged proactive industry preparation: "We're not going to say that it's easy for a transition, but we think the requirements are similar enough that industry can do this."
Paid subscribers get exclusive access to our QMSR gap analysis worksheet here. Contact us if you require expert support in running your assessment and harmonizing your operations—we’re actively working with several device companies on QMSR projects.
Blood lead test accuracy warning issued 💉— The FDA is alerting healthcare providers about false positive risks with ASP Global's RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes used with LeadCare Testing Systems. The agency recommends either avoiding the test or interpreting results cautiously and confirming with alternative methods.
Drug labeling database delays reported 💊 — Axios reports that Drugs@FDA and the National Drug Code Directory show significant gaps in product labeling data following April staffing cuts. This leaves healthcare providers without access to crucial prescribing information including indications, contraindications, dosing guidance, and side effects.
Quality management program extended 💊 — A Federal Register notice indicates the FDA is continuing its voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program administered by CDER's Office of Pharmaceutical Quality.