Federal Register notice: FDA makes available a final guidance entitled Product Identifiers Under the Drug Supply Chain Security Act: Questions and Ans...
Federal Register notice: FDA makes available a final guide entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product a...
Federal Register notice: FDA makes available a draft guidance discussing enhanced drug distribution security at the package level.
FDA acting commissioner Janet Woodcock prepares to testify 6/10 before the Senate Subcommittee on Agriculture, Rural Development, Food and Drug Admini...
FDA clears an Edwards Lifesciences 510(k) for its Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff.
FDA approves a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in overweight adults with obesit...
FDA approves a Chimerix NDA for Tembexa (brincidofovir) for treating smallpox.
FDA issues a clinical hold on a Ortho Regenerative Technologies Phase 1-2 clinical trial for Ortho-R, a drug/biologic combination product candidate us...