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 ...
Attorney Rachel Hunt says FDA will not maintain a public database of breakthrough device designation applications and decisions.
FDA gives recommendations for reducing air-in-line issues associated with infusion pumps rapid infusers, and fluid warmers and their accessory devices...
Federal Register notice: FDA announces a 3/27 Pulmonary-Allergy Drugs Advisory Committee meeting. to discuss a AllerQuest NDA for Pre-Pen Plus, a skin...