Federal Register notice: FDA announces a 5/9-10 workshop to obtain input on issues and challenges associated with federal efforts to support training ...
FDA clears an electroCore 510(k) for the gammaCore vagus nerve stimulator for treating acute pain associated with episodic cluster headache in adult p...
Federal Register notice: FDA and the Critical Path Institutes Patient-Reported Outcome Consortium announce a 4/25 public workshop entitled Second Annu...
Federal Register notice: FDA requests comments on an information collection for its interim final rule Medical Devices; Exception From General Require...
Two professors discuss five challenges facing FDA commissioner-nominee Scott Gottlieb.
A part owner of the defunct New England Compounding Center says he cant be guilty of fraud against FDA because there was no legal bright line differen...
The Coalition for Clinical Trial Awareness asks Congress to include in PDUFA a three-step process to raise awareness of the value of clinical trials a...
FDA denies a Metabolic Therapy petition to amend an OTC monograph to indicate that melatonin and IP6 are safe and effective for analgesic drug product...