Federal Register notice: FDA makes available a revised draft guidance entitled Drug Products Labeled as Homeopathic.
Federal Register notice: FDA withdraws the NDA approval of Allergan Pharmaceuticals Lo Minastrin FE because it is no longer marketed.
Federal Register notice: FDA classifies internal therapeutic massagers into Class 2 (special controls).
FDA grows concerned over recent closures of certain large-scale sterilization facilities that use ethylene oxide to sterilize medical devices prior to...
Abiomed says that a post-approval study confirmed survival data in its pre-approval study for the Impella RP heart pump.
Federal Register notice: FDA announces its decision to exempt a list of Class 2 devices from premarket notification requirements.
Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Studies and Clinical Trials Implementation of Section 505(o)(3) ...
Federal Register notice: FDA makes available its listing of Modifications to the List of Recognized Standards, Recognition List Number: 052.