Federal Register notice: FDAs Circulatory System Devices Panel of the Medical Devices Advisory Committee reviews a Cordis PMA for the Incraft AAA Sten...
Federal Register notice: FDA makes available a guidance entitled Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.
President Trumps blueprint for lowering prescription drug prices orders FDA to require drug companies advertising their drugs to include pricing infor...
FDA expands approval of Novartis Gilenya (fingolimod) to treat relapsing multiple sclerosis in children and adolescents.
Vyaire Medical recalls its AirLife resuscitation devices and Broselow convenience kits due to risk of a malfunction caused by an error in the products...
A group of patient and industry organizations write Congressional leaders urging them to enact legislation to modernize the statutory oversight of cli...
Federal Register notice: FDA seeks comments on an information collection extension for Request for Samples and Protocols (OMB Control Number 09100206)...
Federal Register notice: FDA determines that GE Healthcares sodium iodide I 123 oral solution, 2 millicuries/milliliter was not withdrawn from sale du...