After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in ...
The FDA has chosen Eli Lilly and Regeneron to participate in a new pilot program aimed at speeding up the development and ...
ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox. U.S. inspectors have uncovered new and dangerous ...
Where FDA once channeled its most consequential shifts through Federal Register notices, formal guidance documents and rulemaking, the Makary FDA made many major policy pronouncements via press ...
The FDA has flagged Novo Nordisk's newly acquired manufacturing facility in Indiana with an Official Action Indicated (OAI) label, which is the most severe of the three inspection classifications ...
This article originally appeared on ProPublica. ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.
The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...
When US Food and Drug Administration (FDA) inspectors arrived unannounced at Hetero Labs' warehouse facility in Visakhapatnam, India, on 19 September , they documented conditions that would result in ...
The FDA has made additional reports on inspections of ByHeart infant formula plants available. The company’s formula has been determined to be the source of at least 37 cases of infant botulism. The ...
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