RA/QA News Roll: Late May 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
More clarity on guidance and deregulation — The Trump administration's deregulatory push is raising critical questions about how FDA draft guidance will be impacted by Executive Order 14192. Recent Federal Register notices show FDA intends to align closely with OMB guidance M-25-20, explicitly soliciting public comments on the cost impacts of the new guidance. Companies opposing guidance may strategically argue that costs are significant, compelling the FDA to eliminate ten existing regulations or guidances per the executive order.
FDA union dues collection stopped — Following a March 2025 executive order banning collective bargaining for national security reasons, FDA HR informed union members it will stop automatically collecting union dues effective May 31.
FDA's new AI policy lead — FDA appointed Shantanu Nundy, a physician and former CMO of Accolade Health, to spearhead regulatory policy on artificial intelligence. Nundy's appointment underscores the administration’s emphasis on stronger strategic oversight of AI-based medical products.
New executive order on ‘gold standard science’ — President Trump issued an executive order requiring unprecedented transparency and detailed public documentation of influential scientific decisions across federal agencies, explicitly mandating disclosures of data and uncertainties.
Makary on FDA's budget — FDA Commissioner Makary detailed an 11.5% reduction request in the FY 2026 FDA budget at a recent Senate hearing, emphasizing efficiency while ensuring timely review processes remain unaffected.
Restrictions on FDA publications — HHS Secretary Kennedy indicated FDA scientists might soon be barred from publishing research in prominent medical journals like JAMA, NEJM, and The Lancet, proposing an internal HHS-run journal if external journals refuse to meet new transparency standards.
FDA General
A new guidance history feature 💉 — FDA is gradually introducing a "guidance history" section to medical device guidance documents, intended to enhance clarity about revisions and align with good guidance practices highlighted in a recent agency report.
MAHA report citations updated — After reports surfaced from NOTUS highlighting fabricated and inaccurate citations in the Make America Healthy Again (MAHA) report, the White House updated problematic references. Commissioner Makary attributed errors to "formatting issues," strongly defending the integrity of the report.
Ultraprocessed MAHA report citations — Additional NOTUS reporting revealed significant further citation issues in the MAHA report, including entirely nonexistent sources and other inaccuracies, prompting questions about the document’s overall research integrity.
FDA adopts new ICH guidance 💊 — After months of inactivity under the new administration, FDA released the draft ICH guidance M13B, addressing bioequivalence testing for immediate-release solid oral dosage forms. This action marks a reengagement with the ICH’s international harmonization efforts. Read M13B here.
FDA finalizes Q-sub guidance 💉 — FDA issued a final Q-submission guidance designed to streamline regulatory interactions with medical device developers. Notably, the guidance explicitly declares itself a deregulatory measure under the administration’s broader deregulatory framework.
New guidance on color additive changes 💊 — FDA released guidance clarifying the regulatory process for pharmaceutical companies reformulating medicines to remove petroleum-based color additives. This aligns closely with Commissioner Makary's broader campaign on additive removal from medications and foods.
Big day for drug supply security 💊 — FDA officially began enforcing the enhanced provisions of the Drug Supply Chain Security Act, marking an end to multiple delays. Manufacturers and repackagers must comply immediately, while wholesale distributors and dispensers face upcoming staggered compliance dates.
ACNU implementation begins 💊 — FDA’s Additional Condition for Nonprescription Use (ACNU) rule officially went into effect, fundamentally reshaping over-the-counter drug labeling and marketing requirements after prior administrative delays.
Compliance and Enforcement
FDA opioid darknet takedown 💊 — FDA’s Office of Criminal Investigations participated in Operation RapTor, a major international law enforcement action targeting darknet drug trafficking networks. This extensive operation resulted in the seizure of record amounts of illegal drugs, firearms, and drug trafficking proceeds. FDA’s Deputy Director of OCI, Chad Menster, emphasized FDA's ongoing commitment to disrupting online illegal drug sales, highlighting the serious public health risks posed by darknet drug trafficking.
FTC's Orange Book patent scrutiny 💊 — The FTC intensified its campaign against pharmaceutical companies accused of improperly listing patents in the FDA's Orange Book, a tactic potentially blocking generic competition. The FTC targeted 200 patent listings suspected of inaccuracies or irrelevance, aiming to hold companies accountable for preventing generic drug entry. This renewed effort serves as a warning to branded drug manufacturers about the risks of improperly listing patents to delay generic approvals.