Federal Register notice: FDA makes available a final guidance entitled Technical Considerations for Medical Devices with Physiologic Closed-Loop Contr...
Federal Register notice: FDA makes available a draft guidance entitled Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain ...
Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission Template for Medical Device De Novo Requests.
Federal Register notice: FDA makes available a final guidance entitled Antimicrobial Susceptibility Test (AST) System Devices Updating Breakpoints in...
FDA posts a final guidance entitled Human Prescription Drug and Biological Products Labeling for Dosing Based on Weight or Body Surface Area for Read...
FDA approves a Biogen BLA for Tofidence (tocilizumab-bavi) intravenous formulation, the first biosimilar monoclonal antibody referencing Genentechs ar...
CDERs Office of Generic Drugs Office (OGD) expands its post-pandemic return to in-person face-to-face meetings with industry.
FDA announces a new pilot program to further accelerate the development of novel drug and biological products for rare diseases.
