Federal Register notice: FDA submits for OMB approval an information collection extension for Dispute Resolution Procedures for Science-Based Decision...
FDA extends by three months the user fee review of Salix Pharmaceuticals NDA for Plenvu (NER1006) to review additional data that were recently provide...
FDA grants Xeris Pharmaceuticals an orphan drug designation for its ready-to-use, liquid-stable glucagon for treating hyperinsulinemic hypoglycemia.
Philips Electronics recalls its HeartStart MRx Defibrillator due to a defect in the devices gas discharge tube.
Federal Register notice: FDA submits for OMB approval an information collection extension request for Postmarketing Safety Reports for Human Drug and ...
A new report on cutting drug prices from the White Houses Council of Economic Advisers recommends innovation cost reductions through FDA reforms, amon...
FDA and the Nuclear Regulatory Commission approve NorthStar Medical Radioisotopes RadioGenix System to produce Tc-99m, the most widely used medical im...
FDA touts publication of 57 new and revised product-specific guidances to help generic drug makers know what is required to obtain ANDA approval for a...