FDA Warning Letter Cites AI Use in Pharmaceutical Manufacturing
The FDA has issued a warning letter citing the inappropriate use of artificial intelligence in pharmaceutical manufacturing, raising new concerns around cGMP compliance, data integrity, and oversight. This development signals increased regulatory scrutiny on how AI is implemented within quality systems and production processes.
California DTSC Proposes New Requirements for 1,4-Dioxane in Shampoos and Dish Detergents
California DTSC Proposes New Requirements for 1,4-Dioxane in Shampoos and Dish Detergents The California Department of Toxic Substances Control (DTSC) is proposing to designate manual dish detergents and shampoos containing more than 1 ppm of 1,4-dioxane as “Priority...
FDA Highlights Importance of Confidential Information in Maintaining Regulatory Integrity
FDA Highlights Importance of Confidential Information in Maintaining Regulatory Integrity FDA Emphasizes Role of Confidential Information in Its “Gold Standard” The U.S. Food and Drug Administration has published a new FDA Voices article highlighting the importance of...
FDA Records Access Authority for Cosmetics: Draft Guidance Now Available
The U.S. Food and Drug Administration has announced the availability of a new draft guidance titled “FDA Records Access Authority for Cosmetics: Guidance for Industry.” The document addresses frequently asked questions about FDA’s authority to access records related...