[ Price : $8.95]
A BioProcess International column praises a new FDA final guidance for introducing some flexibilities into approval of cell and ge...[ Price : $8.95]
Two Argent Fox Schiff attorneys describe an FDA proposed rule that would change how some drug manufacturers register their facilit...[ Price : $8.95]
FDAs Cellular, Tissue, and Gene Therapies Advisory Committee votes to recommend approval of Replimune's experimental oncolytic imm...[ Price : $8.95]
Two Latham Watkins attorneys analyze a revised FDA draft guidance on demonstrating substantial evidence of effectiveness in drug a...[ Price : $8.95]
FDA releases the form FDA-483 with three observations from an inspection at the Hayward, CA-based Allure Labs drug manufacturing f...[ Price : $8.95]
FDA accepts for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections in patients undergoing ...[ Price : $8.95]
FDA posts the following user fee rates for medical product programs for fiscal year 2027.[ Price : $8.95]
FDA releases the form FDA-483 with nine observations from an inspection at the Edison, NJ-based Bentley Laboratories over-the-coun...