Federal Register notice: FDA seeks comments on a new information collection for Proposed Suffix for the Proper Name of a Biological Product.
Federal Register notice: FDA makes available a draft guidance entitled Nonproprietary Naming of Biological Products: Update.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 grants Genentech accelerated approval for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable ...
FDA accepts for priority review a Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately con...