[ Price : $8.95]
FDA issues Gasco Industrial Corp. a Form 483 for significant and repeat GMP deficiencies following a 2/17-27 inspection of the com...[ Price : $8.95]
FDA classifies a correction involving certain Argon Medical convenience kits as a Class I recall after identifying risks associate...[ 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Two Latham Watkins attorneys analyze a revised FDA draft guidance on demonstrating substantial evidence of effectiveness in drug a...[ Price : $8.95]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 ...