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.
FDA says it is implementing immediately a new guidance with information about updating susceptibility test interpretive criteria breakpoints and assoc...
FDA publishes a draft guidance on the electronic submission format for de novo medical device requests.
Three people petition FDA to add information from the fluoroquinolone Boxed Warning to the top of the drugs Medication Guide as a way to better inform...
