Federal Register notice: FDA makes available a final guidance entitled Institutional Review Board (IRB) Review of Individual Patient Expanded Access S...
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Peptide Drug Products.
Federal Register notice: FDA announces an opportunity to participate in its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pil...
FDA grants S4 Medical a de novo authorization to market its esolution esophageal deviation device.
Novartis recalls one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml due to crystal formation observed in some bottle...
FDA provides further clarification about a safety alert issued earlier this year that recommended against the use of certain surgical N95 respirators ...
Federal Register notice: FDA makes available a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatment.
Federal Register notice: FDA posts a final guidance entitled Use of International Standard ISO 109931, Biological Evaluation of Medical Devices Part ...
