Federal Register notice: FDA makes available a draft guidance entitled Nonproprietary Naming of Biological Products: Update.
FDA seeks comments on a new information collection related to a proposed Healthcare Professional Survey of Professional Prescription Drug Promotion.
FDA issues a letter to health care providers to alert them to an increasing number of medical device reports associated with surgical staplers for int...
American Health Packaging recalls one lot of valsartan tablets,160 mg , due to the detection of trace amounts of an unexpected carcinogen in the finis...
FDA clears a Zeiss Medical Technology 510(k) for the Cirrus HD-OCT platform, expanding the capabilities of its anterior segment premier module to incl...
FDA says it will no longer require that a suffix be added to the nonproprietary names of existing biological products.
FDA accepts for review a Foamix Pharmaceuticals NDA for FMX101 (minocycline foam, 4%) for treating inflammatory lesions of non-nodular moderate-to-sev...
Federal Register notice: FDA announces a 4/8 Pediatric Advisory Committee meeting to discuss drug development for testosterone replacement therapy in ...