Federal Register notice: FDA proposes to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly failed to file required...
Federal Register notice: FDA announces the renewal of the Nonprescription Drugs Advisory Committee for an additional two years.
Federal Register notice: FDA sends to OMB an information collection extension for Q-Submission Program for Medical Devices.
Federal Register notice: FDA seeks comments on an information collection extension for Testing Communications on Medical Devices and Radiation-Emittin...
A new Government Accountability Office report finds that generic drug companies are having mixed results from FDAs efforts to help them get timely sam...
FDAs Endocrinologic and Metabolic Diseases Advisory Committee unanimously votes to recommend approval for Amarins submission to expand Vascepas (icosa...
FDA clears a Pentax 510(k) for the first duodenoscope with a sterile, disposable elevator component that the agency says will reduce the number of par...
FDA approves a Novartis BLA for Adakveo (crizanlizumab-tmca) for reducing the frequency of vaso-occlusive crisis in sickle cell disease patients.