FDA Records Access Authority for Cosmetics: Draft Guidance Now Available
The U.S. Food and Drug Administration has announced the availability of a new draft guidance titled “FDA Records Access Authority for Cosmetics: Guidance for Industry.”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...
Durbin Introduces Legislation To Improve Transparency and Safety of Dietary Supplements
U.S. Senate Democratic Whip Dick Durbin has reintroduced the Dietary Supplement Listing Act, legislation aimed at improving transparency and safety in the dietary supplement market.
FDA Launches Web-Based Tobacco Premarket Application Forms to Enhance Submission Process
The FDA’s Center for Tobacco Products (CTP) has introduced new web-based versions of key forms used for PMTA and Substantial Equivalence (SE) Report submissions. These updated forms are now available through CTP Portal Next Generation (NextGen), the agency’s enhanced...
FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
The U.S. Food and Drug Administration has announced a significant expansion of its internal artificial intelligence capabilities through the deployment of agentic AI tools across the agency. The new system is designed to help FDA staff manage complex, multi-step tasks...