Federal Register notice: FDA issues a guidance, Safety and Performance Based Pathway, that discusses the agencys current thinking on expanding the con...
Federal Register notice: FDA releases a draft guidance entitled Survey Methodologies to Assess REMS Goals That Relate to Knowledge that gives informat...
Federal Register notice: FDA makes available a draft guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, an...
Federal Register notice: FDA announces a 3/8 Microbiology Devices Panel meeting to discuss and make recommendations on new or alternative approaches t...
FDA clears a Qualigen 510(k) for its FastPack IP Sex Hormone Binding Globulin Immunoassay, a biomarker used in diagnosing and treating mens health.
FDA issues Sunovion Pharmaceuticals a complete response letter on its NDA for apomorphine sublingual film for use in treating off episodes experienced...
FDA commissioner Scott Gottlieb says the agency will take additional steps in 2019 to promote development of generic complex drugs.
Federal Register notice: FDA announces a 3/21 Neurological Devices Panel of the Medical Devices Advisory Committee meeting that will review a de novo ...