In an untitled letter, FDA says Milan, Italy-based Industria Farmaceutica is manufacturing drugs with CGMP violations.
Medexus Pharmaceuticals says FDA has extended the review of its Medac licensors resubmitted NDA for treosulfan and its use in allogeneic hematopoietic...
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FDA posts a draft guidance entitled Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs (CDP).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FDA releases a CVM draft guidance entitled Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.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...
