FDA reports on additional flow-rate accuracy conducted by CME America on its recalled BodyGuard infusion system administration sets.
FDA summarizes Epclusa label changes to cover a new Covid indication.
Researchers from two law schools and a medical school urge FDA to accept and use more subjective evidence in considering treatments for consciousness ...
FDA says it considers an Endologix Ovation iX correction notice as a Class 1 recall.
Federal Register notice: FDA makes available a draft guidance entitled Biomarkers and Surrogate Endpoints in Clinical Studies Support Effectiveness of...
Federal Register notice: FDA makes available a draft guidance entitled Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal D...
FDA approves an Edwards Lifesciences PMA for the Konect Resilia aortic valved conduit, a ready-to-implant device for bio-Bentall procedures.
Federal Register notice: FDA makes available a final guidance entitled Clinical Investigations for Prostate Tissue Ablation Devices.