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.
FDA approves a Shionogi & Co. NDA for Fetroja (cefiderocol), an antibacterial drug for treating patients 18 years of age or older with complicated uri...
FDA funds a $1.7 million two-year project in which five universities will study quality management in FDA drug manufacturing operation inspections.