Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.
A final rule FDA issued in January has shaken industry groups who say it creates a new legal standard for assessing a manufacturer’s “intended use” of a product that will allow any evidence to be used to bring a criminal misbranding action – thus exposing companies to potential liability for normal business activity.
Revisions to the “intended uses” regulations were included in a final rule on tobacco-derived products. “If the totality of evidence...
Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
