Sen. Ron Johnson asks to interview four former CBER officials and Anthony Fauci on the safety and efficacy of Covid vaccines.
FDA accepts for priority review a Johnson & Johnson supplemental BLA for subcutaneous Rybrevant Faspro for adults with recurrent or metastatic head an...
FDA cites contract drug manufacturer Cerovene Inc. for repeat current good manufacturing practice deficiencies following a recent inspection of its Va...
A Friends of Cancer Research survey report documents bottlenecks in U.S. oncology clinical trial site scale-up activation and suggests ways to address...
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...
Two Latham Watkins attorneys analyze a revised FDA draft guidance on demonstrating substantial evidence of effectiveness in drug and biologic trials a...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...
