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FDA issues a partial clinical hold on a BioNTech/Medilink Therapeutics Phase 1 clinical (NCT05653752) trial that is evaluating BNT...[ Price : $8.95]
FDA approves Mercks Keytruda (pembrolizumab) for use with carboplatin and paclitaxel in adult patients with primary advanced or re...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.[ Price : $8.95]
FDA posts a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA that provides information on how the agenc...[ Price : $8.95]
FDA gives a one-item Form FDA-483 to Chugai Pharma Manufacturing Co. after inspecting the firms Utsunomiya, Tochigi, Japan facilit...[ Price : $8.95]
Federal Register notice: FDA corrects a 5/23 notice announcing the availability of a draft revised guidance #115 (VICH GL22) entit...[ Price : $8.95]
CDRH Digital Health Center of Excellence director Troy Tazbaz says that developing a medical device quality assurance practice for...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for the Development of...