FDA Issues Guidance on Enforcement Priorities for Unauthorized ENDS and Nicotine Pouch Products
FDA Issues Guidance on Enforcement Priorities for Unauthorized ENDS and Nicotine Pouch Products FDA Updates Enforcement Priorities for Unauthorized Tobacco Products FDA’s Center for Tobacco Products (CTP) has issued guidance titled “Enforcement Priorities for Certain...
FDA Launches One-Day Inspectional Assessments to Expand Regulatory Oversight
FDA Launches One-Day Inspectional Assessments to Expand Regulatory Oversight FDA Introduces One-Day Inspectional Assessments The U.S. Food and Drug Administration has announced a new initiative called One-Day Inspectional Assessments, designed to expand oversight...
FDA Updates Biosimilar Q&A Draft Guidance
FDA has released updated draft guidance on biosimilar development, clarifying how sponsors can use non-U.S.-licensed comparator products to support biosimilarity and what is required during FDA review.
USDA Announces Creation of Office of Seafood to Strengthen Industry Coordination
USDA Announces Creation of Office of Seafood to Strengthen Industry Coordination USDA Establishes Office of Seafood The U.S. Department of Agriculture has announced the creation of a new Office of Seafood, aimed at strengthening coordination, policy development, and...
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.