On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more
On May 10, the U.S. Food and Drug Administration (“FDA”) released a new guidance document Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution,...more
On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more
12/20/2022
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Draft Guidance ,
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Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
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Prescription Drugs
FDA Continues to Focus on Identifying and Controlling Trace Impurities in Drugs -
On December 23, 2021, the U.S. Food and Drug Administration (“FDA”) alerted drug manufacturers that FDA was investigating the root cause of...more