FDA issues Gasco Industrial Corp. a Form 483 for significant and repeat GMP deficiencies following a 2/17-27 inspection of the company's over-the-coun...
FDA classifies a correction involving certain Argon Medical convenience kits as a Class I recall after identifying risks associated with lidocaine amp...
A BioProcess International column praises a new FDA final guidance for introducing some flexibilities into approval of cell and gene therapy products ...
Two Argent Fox Schiff attorneys describe an FDA proposed rule that would change how some drug manufacturers register their facilities and list their p...
FDAs Cellular, Tissue, and Gene Therapies Advisory Committee votes to recommend approval of Replimune's experimental oncolytic immunotherapy RP1 (vuso...
Two Latham Watkins attorneys analyze a revised FDA draft guidance on demonstrating substantial evidence of effectiveness in drug and biologic trials a...
FDA releases the form FDA-483 with three observations from an inspection at the Hayward, CA-based Allure Labs drug manufacturing facility.
FDA accepts for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal...
