RA/QA News Roll: Late May 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
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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 Leadership and Administration
Senior leadership overhaul follows Makary’s exit: The FDA cleared out much of its senior team in a shake-up. Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research, said she was given the choice to resign or be terminated and chose to be fired. Mike Davis, a former acting director, now leads CDER. Katherine Szarama was moved into an advisor role and replaced as acting CBER director by Karim Mikhail, the former CEO of Amarin who most recently advised Makary. Chief of Staff Jim Traficant was reassigned, with Lowell Zeta taking over his duties. Jeremy Walsh, the FDA’s first chief artificial intelligence officer, resigned, and no successor has been named.
Eight senior roles are now filled on an acting basis: The FDA’s leadership roster includes acting officials in the commissioner, CBER director, CDER director, chief information officer, chief of staff, deputy commissioner for food, associate commissioner for external affairs, and director of the Center for Tobacco Products positions. The breadth of the turnover suggests the agency will stay relatively quiet until a permanent commissioner is confirmed.
The shake-up reads as a clean break from Makary: The removal of Makary’s close advisors appears deliberate, a signal that leadership decisions had been made by multiple people rather than one. Acting Commissioner Kyle Diamantas has reportedly so far kept a low profile, sticking to traditional announcement channels rather than the frequent podcast and conference appearances his predecessor favored.
Commissioner search narrows as candidates rule themselves out: Brett Giroir, a former acting commissioner, wrote that he asked not to be advanced for the role, citing family and work obligations. Former Commissioner Stephen Hahn joined Turn Therapeutics as its executive clinical and regulatory lead, which all but ends speculation about his return. Former Oncology Center of Excellence Director Rick Pazdur spoke at a healthcare conference but stopped short of putting his name forward. Houman Hemmati, an ophthalmologist and biotech executive, posted a photo from the office of Sen. Tommy Tuberville (R-Ala.), a member of the committee that will vote on the next commissioner.
Oncology staff departures continue: Paz Vellanki, most recently associate director of the Division of Oncology 2, which oversees lung, head, and neck cancers, left to join Precision for Medicine as vice president of clinical development for oncology. The exit adds to a steady run of oncology departures over recent months.
FDA General
PDUFA technical negotiations have wrapped up: 💊 The FDA concluded technical negotiations on the Prescription Drug User Fee Act commitment letter, the document that sets out what the agency will do over a five-year period in exchange for industry user fees. Several steps remain before the letter is finalized, including FDA and industry ratification, HHS and OMB clearance, public comment, re-clearance, and transmittal to Congress. Those steps have historically taken several months, with the text usually available in late summer or fall.
CNPV program will be reassessed, and its council role is shrinking: 💊 The Commissioner’s National Priority Voucher program will continue despite Makary’s departure, but the FDA plans to reassess it after a June 4 input meeting. The agency is also making one notable change: the council of senior FDA leaders that initially weighed in on approval decisions will no longer be routinely required for applications. That council’s early prominence had raised concerns about political interference in drug reviews. The change could shift the program to function more like Real-Time Oncology Review.
Real-time trials pilot gets a longer comment window: 💊 The FDA extended the comment period for its early-phase real-time clinical trials pilot by 30 days, to June 29, after the Alliance for Regenerative Medicine asked for more time. The agency had wanted to set selection criteria by July and complete selections by August. The future of the effort is uncertain: Jeremy Walsh, who led the pilot and coordinated the broader real-time trials work, resigned within hours of leading a May 15 industry session, and the broader project no longer has a clear internal champion.
Final human factors guidance published: 💉 The FDA released its final guidance on the content of human factors information in medical device marketing submissions, a document it had worked on for a decade with drafts in 2016 and 2022. Human factors covers how a device will be used and the testing needed to confirm that intended and actual use don’t cause errors or safety problems. CDRH described the guidance as deregulatory, intended to reduce the amount of human factors information manufacturers must submit based on risk. The document carries a minimum 60-day implementation timeline and runs 20 pages longer than the 2022 draft, mostly because of three new appendices.
Draft guidance streamlines nonclinical safety studies for oncology drugs: 💊 A new draft guidance supports streamlined approaches that avoid unnecessary animal use for oncology biologics and conjugated products. Sponsors can propose alternatives to the standard three-month general toxicology studies, including non-sacrificial study designs, designs that reduce animal numbers, or a weight-of-evidence risk assessment for products with well-understood targets. Sponsors can supplement these with data from new approach methodologies given appropriate scientific justification. The FDA said the guidance could also shorten oncology development timelines.
Final M11 guidance on electronic structured protocols: 💊 The FDA published the final M11 guidance, finalized last year by the International Council for Harmonisation. It provides a template for the ICH’s Clinical Electronic Structured Harmonised Protocol (CeSHarP) and defines key terms, page elements, and formatting.
71 new and revised product-specific generic guidances: 💊 The FDA released 71 product-specific guidances that help generic developers design acceptable bioequivalence studies. The batch includes guidances tied to drugs such as Otezla, Procysbi, Qfitlia, Rytelo, Gomekli, and Brukinsa.
Two final generic bioequivalence guidances: 💊 The FDA finalized two guidances on generic drug bioequivalence. One is a practical how-to for designing studies using pharmacokinetic endpoints. The second covers statistical approaches to establishing bioequivalence.
Food-effect guidance updated: 💊 The FDA made minor updates to its 2022 guidance on assessing how food affects investigational drugs, including grammatical changes and the removal of an appendix of labeling examples. The agency did not explain why the appendix was removed.
BSUFA negotiations continue: 💊 The FDA and the biosimilars industry are still working through proposals for the next Biosimilar User Fee Act agreement. At an April 16 meeting, the agency responded to an industry proposal on supplement classifications for chemistry, manufacturing, and control issues, shared a counterproposal on the Pediatric Research Equity Act, and heard a new industry plan on Investigational New Drug protocols.
Outlook wins dispute resolution appeal on eye drug: 💊 After three rejections, Outlook Therapeutics won an appeal through the FDA’s formal dispute resolution process for its ophthalmic formulation of bevacizumab, which treats neovascular age-related macular degeneration. The FDA determined the company had established substantial evidence of effectiveness and directed its review offices to work with Outlook on final labeling. Outlook plans to resubmit in June and expects a Class 1 classification with a decision about 60 days later.
Camizestrant decision date pushed: 💊 AstraZeneca said the FDA extended the user fee goal date for camizestrant in combination with a CDK4/6 inhibitor for first-line treatment of certain advanced breast cancers with an emergent ESR1 mutation. The extension gives the agency time to review additional requested data, including ctDNA clearance data linked to longer-term efficacy. An advisory committee voted 6-3 against the drug’s demonstrated benefit in late April, finding the circulating tumor DNA switching paradigm in the pivotal trial unsupported by the data.