FDA releases its latest batch of Warning Letters that includes Baja Fur, Dental-Kosmetik, Draegar Medical Systems and Sunstar Guangzhou.
FDA approves Mercks Dificid (fidaxomicin) oral suspension and tablets for expanded use treating Clostridium difficile infections in children aged six...
FDA posts a draft guidance on Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions.
FDA launches a new Web page to help companies advance development of novel coronavirus medical countermeasures.
Federal Register notice: FDA withdraws approval of a new animal drug application and two abbreviated new animal drug applications because they are no ...
Federal Register notice: FDA extends until 3/19 the comment period for its draft guidance on Demonstrating Substantial Evidence of Effectiveness for H...
Federal Register notice: FDA makes available a final guidance entitled Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual...
FDA seeks comments on two proposed studies entitled Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.