A former Becton Dickinson medical director petitions FDA to scrutinize the companys 2017 510(k) clearance for the GalaForm 3D due to label misreprese...
FDA announces a 5/2 Webcast entitled Navigating the First ICH Generic Drug Draft Guideline M13A Bioequivalence for Immediate-Release Solid Oral Dosag...
FDA warns Chatsworth, CA-based Formology Lab about CGMP violations in its production of drugs as a contract manufacturer.
FDA warns Houston, TX- based Dr. Maggie Jeffries/Avanti Anesthesiology about conducting a clinical investigation without a required IND.
Federal Register notice: FDA makes available a final guidance for industry entitled Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Red...
Federal Register notice: FDA revokes the Emergency Use Authorizations for Covid-issued to Abbott Diagnostics and Standard BioTools for their Covid-19 ...
FDA amends the emergency use authorization for the Pfizer-BioNTech Covid-19 bivalent vaccine and its use as a single booster dose to include children ...
FDA places a clinical hold on Mersana Therapeutics Phase 1 trial of XMT-2056 after the company suspended it due to a recent patient death that was dee...
