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Federal Register notice: FDA makes available a draft guidance entitled Graft-versus-Host Diseases: Developing Drugs, Biological Pr...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission Template for Medical Device De Novo R...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Antimicrobial Susceptibility Test (AST) System Devices Upd...[ Price : $8.95]
FDA posts a final guidance entitled Human Prescription Drug and Biological Products Labeling for Dosing Based on Weight or Body S...[ Price : $8.95]
FDA approves a Biogen BLA for Tofidence (tocilizumab-bavi) intravenous formulation, the first biosimilar monoclonal antibody refer...[ Price : $8.95]
CDERs Office of Generic Drugs Office (OGD) expands its post-pandemic return to in-person face-to-face meetings with industry.[ Price : $8.95]
FDA announces a new pilot program to further accelerate the development of novel drug and biological products for rare diseases. ...[ Price : $8.95]
FDA says it is implementing immediately a new guidance with information about updating susceptibility test interpretive criteria b...