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Fierce Biotech13h
FDA releases ‘initial batch’ of more than 200 drug rejection letters
The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...
STAT8h
NIH grant cuts, FDA transparency questions, and biotech M&A
On this week's episode of "The Readout LOUD": a closer look at the NIH’s grant-cutting legal playbook, FDA transparency ...
FDA Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
BioSpace11d
FDA’s AI Rollout Raises Questions Around Readiness, Legality
The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...
FDA to "review the latest data" on mifepristone. What could it mean for access to the abortion pill?
HHS Secretary Robert F. Kennedy Jr. asked the FDA "to review the latest data on mifepristone​," but experts say concerns ...
FDA vaccine official restricted COVID vaccine approvals against agency advice
A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...
STAT2mon
Five questions about FDA's speedy rollout of AI for scientific review
5 burning questions about FDA’s ‘aggressive’ deployment of AI for scientific review. Commissioner Makary wants a new AI tool deployed across the agency’s review offices by the end of June.
Chocolate Recall Update as FDA Sets Risk Warning
Meijer Inc. announced a recall of thousands of cases of Frederik's Dark Chocolate Almonds on June 13 due to the possible ...
The Washington Post1mon
FDA to issue new vaccine approval guidance amid questions over ...
FDA to issue new vaccine approval guidance amid questions over coronavirus shots. FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming ...
Cleveland.com1mon
FDA’s new approach raises questions about fall COVID vaccine availability
FDA’s new approach raises questions about fall COVID vaccine availability Published: May. 21, 2025, 9:47 a.m. FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is ...