RA/QA News Roll: Late June 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
FDA job cuts vs. ‘trains on time’ narrative — KalVista disclosed a four‑week PDUFA delay, citing FDA “heavy workload and limited resources,” the first public indication that post‑RIF staffing is stretching review clocks. (We are not seeing extended review times for user-fee-funded activities.)
Tougher performance reviews for staff — OPM issued new, stricter five‑point government‑wide performance standards meant to end “ratings inflation.” The FDA HR must now implement them agency‑wide.
$100 M White House re‑org — A Senate HSGAC spending bill would hand the Administration funds to reorganize agencies—FDA included—without separate congressional approval.
Prasad becomes FDA’s first Chief Medical and Scientific Officer — Beyond running CBER, Vinay Prasad will now advise on cross‑center scientific policy and major regulatory decisions.
AI leadership churn 💊💉 — CDER’s AI policy chief Tala Fakhouri exits as Chief AI Officer Jeremy Walsh gears up “Elsa 2.0,” integrating PubMed and reviewer feedback loops.
FDA General
Some highlights from DIA:
Makary signals application “page‑limit” plan — At DIA, Commissioner Makary said 100k‑page NDAs can’t continue, hinting at size caps and clearer data expectations to curb “reviewer data demands.”
15‑minute reviewer calls in the works — Makary told DIA attendees he’s examining routinized “quarter‑hour check‑ins” so sponsors can clarify expectations and avoid months of unnecessary work.
Big‑data vision could lower pre‑market evidence bars — Makary previewed a cloud‑based, real‑time pharmacovigilance system he claims will justify leaner pivotal trials.
CDER leadership shake‑up 💊 — Acting Director Jacqueline Corrigan‑Curay will retire in July; former Amarin CEO Karim Mikhail is reportedly Makary’s choice for permanent director, while psychedelic‑medicine expert Mike Davis re‑joins as Deputy Director.
Gene‑therapy turmoil 💊 — CBER placed Office of Therapeutic Products heads Nicole Verdun and Rachael Anatol on leave. Nephrologist Vijay Kumar is acting lead amid safety debates over CAR‑T and Duchenne products.
Autologous CAR‑T REMS lifted 💊 — FDA dropped REMS for BCMA‑ and CD19‑directed autologous therapies, citing sufficient real‑world experience and labeling to manage CRS/neurotoxicity.
Serious antibacterial therapies final guidance 💊 — The FDA has replaced its 2013 draft, detailing flexible clinical-evidence expectations for drugs targeting multi-drug-resistant organisms and other unmet-need infections.
110‑page ICH Q1 & Q5C stability omnibus 💊 — The FDA adopted the ICH “stability mega‑guidance,” consolidating climate‑zone, biologic post‑approval and stress‑testing principles without U.S.-specific tweaks. We broke it down here for paid subscribers:
Form 3500/3500A/B overhaul proposal 💊 — Planned FAERS changes would drop a gender field, collapse race/ethnicity, add purchase‑location data, and reroute dietary‑supplement AEs to the Safety Reporting Portal.
