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FDA summarizes Epclusa label changes to cover a new Covid indication.[ Price : $8.95]
Researchers from two law schools and a medical school urge FDA to accept and use more subjective evidence in considering treatment...[ Price : $8.95]
FDA says it considers an Endologix Ovation iX correction notice as a Class 1 recall.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Biomarkers and Surrogate Endpoints in Clinical Studies Supp...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Adaptive and Other Innovative Designs for Effectiveness Stu...[ Price : $8.95]
FDA approves an Edwards Lifesciences PMA for the Konect Resilia aortic valved conduit, a ready-to-implant device for bio-Bentall p...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Clinical Investigations for Prostate Tissue Ablation Device...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance on medical devices submissions in an electronic format.