RA/QA News Roll: Mid 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
FDA Launches Deregulatory Effort — HHS and FDA issued a public request for information aimed at identifying regulations to eliminate, aligning with President Trump’s 10-for-1 rule and regulatory cost cap. The notice asks six key questions and invites comments for 60 days. HHS Secretary Kennedy emphasized that the intent is to assist small companies by eliminating burdensome requirements, even if currently supported by some stakeholders. See the Federal Register notice here.
“Most Favored Nation” Drug Pricing Executive Order 💊 — President Trump signed an executive order targeting drug pricing disparities, instructing the FDA Commissioner to explore consistent waiver pathways for importing lower-cost prescription drugs from other developed countries and potentially revoke approvals of drugs deemed improperly marketed or overpriced in the U.S.
Federal Judge Pauses FDA Staff Reductions — A U.S. district judge temporarily halted the Trump administration’s Reduction in Force (RIF) actions affecting FDA staff, citing constitutional concerns raised by labor unions. The decision delays the terminations originally scheduled for early June. A rally by the FDA's union is also planned at the White Oak campus.
MAHA Report Release Imminent — HHS Secretary Kennedy announced that the Make America Healthy Again (MAHA) Commission will release its report this week. The report is expected to influence FDA policy—particularly on vaccines and public health—and could distill Kennedy’s theories about causation in chronic health conditions.
Executive Orders Target Federal Register Delays — A new order calls for modernizing the Office of the Federal Register to reduce publication delays of new regulations, citing inefficiencies that have led to multi-day or multi-week delays in rule dissemination.
FDA General
Vinay Prasad Named CBER Director 💊 — Commissioner Makary appointed oncologist and FDA critic Vinay Prasad to lead the Center for Biologics Evaluation and Research. In his first staff address, Prasad emphasized trust through rigorous standards and announced a new telework policy allowing two remote days per week. His appointment signals a shift in CBER’s direction, with implications for vaccines and cell/gene therapy oversight.
FDA Moves to Remove Pediatric Fluoride Tablets 💊 — The FDA plans to remove ingestible fluoride tablets for children from the market by October 31, citing potential harm to the microbiome. The move has drawn criticism from pediatric dental groups, which dispute the scientific basis. FDA characterized these drugs as never approved under modern regulatory standards, though they were previously included in the anticaries monograph.
First AI-Assisted Product Review Completed — The FDA completed its first AI-assisted product review under a new pilot. The initiative—led by new Chief AI Officer Jeremy Walsh and Sridhar Mantha—is targeting full implementation across the agency by June 30. The agency is also exploring a generative AI tool tentatively named “cderGPT” to streamline review workflows.
At-Home Cervical Cancer Test Approved 💉— Teal Health’s self-collection cervical cancer screening test became the first FDA-approved at-home option, potentially expanding access to preventative care and early detection.
New Oncology Engagement Pilot Announced 💊 —The FDA’s Oncology Center of Excellence launched “Project Interface,” a new pilot aimed at engaging patient advocates, faith-based groups, and professional organizations to promote cancer awareness and regulatory collaboration. The program appears to replace the discontinued “Project Community.”
PDUFA Date Extension, AdComm for Biohaven 💊 — Biohaven announced that the FDA’s Division of Neurology 1 has extended the PDUFA target date for the company's NDA for troriluzole, a proposed treatment for spinocerebellar ataxia (SCA), by three months. The extension is intended to provide time for a complete review of recent submissions related to FDA information requests. The agency also notified Biohaven of its intent to convene an advisory committee meeting to discuss the application later this year.
FDA Updates Recall Audit Form — FDA revised Form 3177 (Recall Audit Check Report) to reflect ongoing improvements in its postmarket monitoring and compliance auditing practices.
Compliance and Enforcement
Clinical Trial Protocol Violations Cited 💊 — A warning letter to a clinical investigator detailed protocol violations, including enrolling patients outside of the trial's BMI requirements. One subject had a BMI of 46.6 kg/m², far above the ≤30 kg/m² threshold.
Data Integrity Failures in India 💊 — An Indian drug manufacturer received a warning letter citing critical data integrity issues. One piece of equipment was labeled clean despite visible product residue and a fraying rope inside. Data backup procedures were also misconfigured, with backups stored on a corrupted local drive rather than the required cloud server.