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Federal Register notice: FDA makes available a draft guidance entitled Biomarkers and Surrogate Endpoints in Clinical Studies Support Effectiveness of...
Federal Register notice: FDA makes available a draft guidance entitled Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal D...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.
Federal Register notice: FDA makes available a final guidance on medical devices submissions in an electronic format.
A Pennsylvania federal judge says a generic drug price-fixing case against Teva will move forward as a bellwether to explore claims of an overarching ...