Federal Register notice: FDA classifies quantitative viral nucleic acid tests for transplant patient management into Class 2 (special controls).
FDA publishes a guidance on integrating clinical trials into routine clinical practice.
FDA issues a safety alert about an increased risk of thigh bone fracture after surgery with the use of the Zimmer Biomet CPT Hip System Femoral Stem 1...
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FDA posts a draft guidance entitled Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs (CDP).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FDA releases a CVM draft guidance entitled Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.
