Federal Register notice: FDA makes available a draft guidance entitled Considerations for Generating Clinical Evidence From Oncology Multiregional Cli...
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...
FDA publishes a guidance on the conduct of clinical trials with decentralized elements.
FDA warns Joliet, IL-based TJA Health about CGMP violations in its manufacturing of finished drugs.
FDA warns Fort Worth, TX-based Quality CDMO that it is marketing five unapproved new drugs.
PhRMA asks FDA to consider a phased approach to enforcing the Drug Supply Chain Security Act because many drug company trading partners may not be rea...
