FDA clears a BioCircuit Technologies 510(k) for its nerve repair device, Nerve Tape, a sutureless option for surgical repair of transected nerves.
Federal Register notice: FDA makes available a draft guidance entitled Human Prescription Drug and Biological Products Labeling for Dosing Based on W...
Federal Register notice: FDA has made available a draft guidance entitled Evaluation of Therapeutic Equivalence that explains how it evaluates generic...
FDA says it has cleared the Renuvion APR Handpiece for specific subcutaneous dermatological and esthetic procedures.
Michigan Gov. Gretchen Whitmer urges FDA to eliminate all REMS restrictions from the mifepristone abortion drug.
The Advanced Medical Technology Association urges the House and Senate to come to terms on a FDA user fee reauthorization package that includes diagno...
Federal Register notice: FDA announces a 9/22-23 Oncologic Drugs Advisory Committee meeting that will discuss an NDA for Spectrum Pharmaceuticals pozi...
Federal Register notice: FDA determines that Fresenius Kabis Xylocaine (lidocaine hydrochloride) topical solution 4% was not withdrawn from sale due t...