FDA Webview posts the Federal Register notices for the week ending 11/30/2018.
A New England Journal of Medicine online perspective reviews the success on FDAs Sentinel medical product safety system that was launched 10 years ago...
CDER posts a Manual of Policies and Procedures to update policy on Drug Shortage Management.
FDA clears a Meridian Bioscience de novo submission for a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus in new...
A new Government Accountability Office report recommends that FDA ensure that information from orphan drug designation applications is consistently re...
Federal Register notice: FDA makes available a draft guidance entitled Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.
Federal Register notice: FDA makes available a draft guidance entitled Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.
Federal Register notice: FDA announces a 1/16 Bone, Reproductive and Urologic Drugs Advisory Committee meeting to discuss an Amgen BLA for osteoporosi...