RA/QA News Roll: Late February 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
Makary announces staff bonus program for expedited reviews 💊💉 — Bloomberg first reported plans to provide bonuses to FDA staff for reviewing products ahead of goal dates, with Associated Press confirming a formal announcement to staff. The program starts on April 1 with August payouts based on time saved, review quality, and work complexity. Makary acknowledged potential controversy, stating, “If you don’t like it, we can get rid of it, but usually everybody loves money.”
Prasad faces sprawling harassment investigation 💊 — Endpoints News reports FDA employed outside investigator Professional EEO Services for “sprawling” months-long probe into CBER Director following personnel complaints, including sexual harassment, retaliation against subordinates, verbally berating staff, and creating a toxic workplace environment. The investigation is described as ongoing, with sparse details available.
POLITICO reports Kennedy being reined in for midterm elections 💊 — A POLITICO report indicates the White House is signaling Kennedy should “lay off the shots” after Trump pollster Tony Fabrizio found childhood vaccine schedule changes unpopular. An HHS leadership shake-up driven by “desire to refocus on drug pricing and other popular elements” of the health agenda.
Makary defends Prasad against media “fatwa” 💊 — The FDA commissioner told CNBC there’s been an “effort to put a fatwa on Vinay Prasad by one or two media outlets” while defending the agency against claims of inconsistent rare disease reviews.
FDA General
FDA reverses course on Moderna flu vaccine review 💊 — The Agency accepted an amended application for mRNA-1010 with an August 5 target decision date after initially refusing to file. The company proposed full approval for ages 50-64 and accelerated approval for 65+, resembling the path Makary outlined in the Fox Business interview. About-face follows Type A meeting and underscores criticism that FDA decision-making has become “more inconsistent and idiosyncratic.”
Single-trial standard becomes new default 💊 — Makary and Prasad published a New England Journal of Medicine piece announcing the shift from “dogma” requiring two pivotal studies to a single-trial default. The new approach places the onus on the agency to determine when additional studies are necessary, with authors arguing that “powerful alternative ways” exist for clinical credibility beyond requiring manufacturers to “test them yet again.”
Plausible mechanism pathway launches for ultrarare diseases 💊 — HHS announced the launch of a new regulatory pathway at an event featuring Secretary Kennedy and Commissioner Makary. The draft guidance provides operational details for individualized therapies treating one or a small number of patients, emphasizing gene editing and antisense oligonucleotide products. CDER Acting Director Høeg predicted the pathway will “inspire industry” and the FDA will be “overwhelmed with applications.”
Makary outlines expansive OTC vision 💊 — The FDA commissioner told CNBC he thinks “everything should be over the counter” unless unsafe, requiring lab monitoring, potentially addictive, or useful for “nefarious purpose.” Plans to act through “proper regulatory processes with rulemaking,” including monograph changes, suggesting vaginal estrogen and nausea medications as candidates for “mass transition” from prescription status.
Second CNPV approval granted with documentation delays 💊 — The FDA expanded Boehringer’s Hernexeos (zongertinib) approval in 44 days under the Commissioner’s National Priority Voucher program for HER2-targeting lung cancer therapy. However, key regulatory documents, including approval letters and updated labeling, remain unavailable in the Drugs@FDA database, limiting stakeholder access to prescribing information.
