RA/QA News Roll: Mid July 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.
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.
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
RIF actions imminent after Supreme Court ruling — The Supreme Court lifted a hold on federal employee terminations, clearing the way for staff reductions to begin.
Hiring freeze extended through October 15 — A White House memorandum extends the federal hiring freeze, limiting FDA's ability to fill its 15 currently open positions until at least mid-October.
DEI court victory — U.S. District Court ruled that removal of diversity-related documents violated the Administrative Procedure Act, potentially reinstating FDA's Project Equity and related guidances.
Commissioner's 100-day milestone — Makary celebrated his first 100 days highlighting animal testing reduction, the CNPV program, new COVID vaccine framework, CEO listening tour, and removal of CAR-T REMS restrictions.
Makary's voucher program to consider pricing 💊 — In Bloomberg and CNBC interviews, Commissioner Makary confirmed drug affordability will be a factor for Commissioner's National Priority Voucher eligibility, with companies promising price equalization between U.S. and foreign markets receiving priority.
Only one dermatologist remains at CDRH 💉 — Internal staffing data reveal CDRH’s dermatology review capacity is down to a single full-time reviewer, illustrating broader expertise gaps following the hiring freeze.
FDA General
CRL transparency initiative underwhelms 💊 — FDA's "radical transparency" announcement of 200+ Complete Response Letters turned out to be mostly repackaging of already-public information from approved products' Drugs@FDA packages, not new revelations about rejected applications.
Senate advances FDA funding — The Senate Appropriations Committee unanimously voted to provide the FDA $7.015 billion for FY2026, approximately the same as 2025 levels and higher than the House's proposed $6.8 billion cut.
Aluminum-labeling guidance for parenteral nutrition products 💊 — A new draft guidance clarifies aluminum concentration calculations, toxicity warnings, and labeling requirements for small-volume parenterals used in parenteral nutrition, foreshadowing near-term QC and labeling updates for sterile-injectable manufacturers.
ADHD extended-release stimulant label update 💊 — Class labeling now warns of clinically significant weight loss in children under six, harmonizing pediatric safety language across all ER amphetamine and methylphenidate products.
Myelodysplastic syndromes drug-development guidance 💊 — Another new draft sets out a life-cycle framework—from non-clinical through post-approval—to streamline MDS therapy development, giving sponsors clearer study-design and endpoint expectations.
User fee reauthorizations moving forward 💊💉 — Despite concerns about Kennedy's industry stance, Commissioner Makary provided supportive opening remarks at the GDUFA kickoff meeting, recognizing the program's importance for delivering low-cost products. More on the meeting here.