Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...
The FDA is planning to only ask for one pivotal clinical trial instead of the long standard of two trials for drug approval. The present FDA commissioner believes it carries the same statistical power ...
The health secretary announced plans to reverse an FDA decision on several of the drugs.
The FDA granted priority review to rusfertide, a potential therapy for polycythemia vera; a decision regarding approval is ...
Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027.
Vanda Pharmaceuticals’ seven-year ambition to score a coveted label expansion for sleep drug Hetlioz has taken an unusual turn, with the FDA acquiescing to a formal hearing on the matter. | The ...
The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...
The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements ...
Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Mario Aguilar covers technology ...
(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...
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