CDERs Office of New Drugs says an advisory committee meeting will be convened to review an Avenue Therapeutics dispute resolution request regarding it...
Federal Register notice: FDA announces a 12/10 meeting of the Medical Devices Advisory Committees Neurological Devices Panel that will review a Brains...
FDA posts a six-observation Form FDA-483 after inspecting a Biocon drug substance manufacturing facility in Malaysia.
CDRH creates a patient resource Web page to provide information about endometrial ablation for heavy menstrual bleeding.
FDA Review posts the Federal Register notices for the week ending 10/22/2021.
FDA Review posts product approval summaries for the week ending 10/22/2021.
Federal Register notice: FDA makes available a draft guidance entitled Data Standards for Drug and Biological Product Submissions Containing Real-Worl...