FDA issues SSM St. Clare Health Center a 10-observation Form FDA-483 for GMP deficiencies found during an inspection at an outsourcing facility in Fen...
FDA posts a draft guidance entitled Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs (CDP).
Federal Register notices: FDA classifies three devices into Class 2 based on de novo classification requests Saladax Biomedicals MyCare Psychiatry Cl...
FDA releases a CVM draft guidance entitled Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.
FDA clears an Apple 510(k) for its Apple Watch to be used as an over-the-counter device for assessing the risk of sleep apnea.
Boehringer Ingelheim plans an NDA for nerandomilast for treating idiopathic pulmonary fibrosis (IPF) after reporting that its Phase 3 FIBRONEER-IPF st...
Fresenius Kabi recalls (Class 1) one lot of the Ivenix Large Volume Pump primary administration sets after documenting a manufacturing defect.
FDA removes a partial clinical hold on Zentalis Pharmaceuticals azenosertib studies into the drugs use against solid tumors and two cancer types.
