FDA accepts for review a AlgoDx de novo marketing request for Navoy Sepsis, a clinical decision support software for predicting sepsis in adult patien...
FDA says a Philips Web site report on the number of replacement and remediated BiPAP and CPAP devices shipped to consumers overstates the number that ...
The Justice Department seeks emergency relief from the U.S. Supreme Court after the Fifth Circuit Court of Appeals ruled that the abortion drug mifepr...
Federal Register notice: FDA makes available a draft guidance entitled Over-the-Counter Monograph Order Requests (OMORs): Format and Content.
Federal Register notice: FDA announces a request for information and comments on the development of an FDA data and technology strategic plan.
FDA medical reviewers ask two advisory committees to consider whether there is a population of Alzheimers patients for whom Otsuka and Lundbecks Rexul...
The Texas House approves a bill to establish a state program that would allow the importation of some drugs from Canada.
Federal Register notice: FDA makes available a final guidance entitled A Risk- Based Approach to Monitoring of Clinical Investigations Questions and ...
