RA/QA News Roll: Late 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.
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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
CBER Director Prasad resigns amid mounting pressure 💊 — CBER Director Vinay Prasad resigned late July 29, citing a desire not to be a "distraction" to the FDA's mission after facing significant pressure from various stakeholder groups. Conservative voices criticized his approval of mRNA COVID-19 vaccines, CBER's regulatory treatment of Sarepta's Elevidys, and past statements at odds with President Trump. George Tidmarsh will serve as acting CBER director while also leading CDER, assisted by deputy directors Scott Steele and Brittany Goldberg.
Conservative attacks on Prasad had intensified 💊 — Laura Loomer, a close Trump confidant, published an extensive critique calling Prasad a "progressive leftish saboteur undermining President Trump's FDA." The Wall Street Journal editorial board member Allysia Finley labeled him "a Bernie Sanders acolyte in MAHA drag," while Bob Goldberg questioned his alignment with Trump's regulatory philosophy, specifically citing concerns about his regulation of Sarepta's Elevidys and past opposition to Right-to-Try legislation.
White House grants ethylene oxide extension 💉 — President Trump signed a proclamation granting a two-year extension for medical device sterilization facilities to comply with EPA emissions standards, citing a lack of commercially viable implementation technology and potential impacts on medical device supply.
Makary reverses quarter of DOGE job cuts — FDA Commissioner Martin Makary revealed he reinstated roughly a quarter to a third of approximately 2,000 FDA employees initially targeted in April's reduction-in-force effort led by the Department of Government Efficiency. Makary confirmed no additional layoffs are planned and acknowledged the agency faces a higher-than-average job vacancy rate while posting hundreds of positions for scientific reviewers.
Makary wants more "continuous trials" 💊 — In interviews with Epoch Times and C-SPAN, Commissioner Makary expressed sustained interest in "continuous" clinical trials that seamlessly adapt and expand based on prespecified interim analyses rather than having distinct phases. He argued the current system wastes time with repeated applications between phases, comparing it to "applying for college after every year of college."
Digital Health Center of Excellence acting director departs 💉 — Sonja Fulmer, who served as acting director of the FDA's Digital Health Center of Excellence for over 10 years, left the agency amid major reshuffling of CDRH's digital health division leadership following the January departure of former director Troy Tazbaz.
FDA hires radiologist for AI efforts 💉 — The FDA brought on radiologist Rick Abramson from Vanderbilt University to support the agency's artificial intelligence initiatives. Abramson previously served as Vanderbilt's first vice chair for innovation in its radiology department.
New acting external affairs leader named — Caleb Michaud was appointed acting associate commissioner for external affairs, leading the Office of External Affairs. He previously served as director of organizational communication and engagement in the FDA's Office of Inspections and Investigations.
FDA General
George Tidmarsh named new CDER Director 💊 — Former biotech executive George Tidmarsh joined the FDA as the new director of the Center for Drug Evaluation and Research. Tidmarsh brings extensive academic credentials with over 100 journal publications and patents, founded Stanford's Master of Translational Research and Applied Medicine program, and led the successful clinical development of seven FDA-approved drugs while serving as founder and CEO of multiple biopharmaceutical companies.
Commissioner's National Priority Voucher Program opens 💊 — The FDA formally began accepting applications for the CNPV program, providing details on submission requirements, including a 350-word maximum description. The program now explicitly includes priorities like "increasing affordability" and "onshoring drug development and manufacturing," with companies limited to a single application. The FDA Law Blog has a great piece on this here.
FDA budget advances in Senate — The Senate is preparing to pass the FDA's annual budget as part of a "minibus" spending bill combining Agriculture-FDA, Military Construction/Veterans Affairs, and Commerce/Justice/Science appropriations, with an amendment submitted by Sen. Susan Collins.
Makary promotes "user-friendly FDA" — Commissioner Makary articulated a vision for making FDA more user-friendly through "better communications, more transparency and predictable guidance" to help inventors and drug developers more efficiently bring treatments to patients, emphasizing his desire to see American companies thrive.
FDA's AI tool "Elsa" reported unreliable — CNN investigation found FDA's new artificial intelligence tool generates fabricated drug studies and requires extensive fact-checking, undermining claimed efficiency gains. Three FDA employees and internal documents confirmed the tool "hallucinates" nonexistent studies or misrepresents research.