FDA says the Baxter Healthcare recall of its Volara system due to risk of respiratory distress in home use is Class 1.
New York University bioethicist Arthur Caplan says those calling for greater diversity in clinical trials should clearly explain the benefits of such ...
Federal Register notice: FDA seeks nominations for voting members to serve on CDRHs Medical Devices Advisory Committee device panels.
FDA says it is considering an additional Sterilization Master File Pilot Program for sterilization changes to 510(k) cleared medical devices.
Federal Register notice: FDA makes available a draft guidance for industry entitled Inspection of Injectable Products for Visible Particulates.
Federal Register notice: FDA classifies the manual percutaneous surgical set assembled in the abdomen into medical device Class 2 (special controls).
CDER Office of Compliance director Donald Ashley says the Center has ramped up its enforcement of ClinicalTrials.gov compliance, specifically registra...
FDA researchers work with industry and clinicians to determine the best way to apply modeling information to improve pediatric dose selection for rena...