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 announces a 1/11/2019 joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Comm...
FDA issues two draft guidances with studies and information it recommends be included in 510(k) submissions for blood glucose monitors intended for he...
Federal Register notice: FDA issues 22 new and 41 revised ANDA product-specific guidances.
Federal Register notice: FDA makes available a draft guidance entitled Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments ...
Federal Register notice: FDA announces a 1/17/2019 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Sanofi-Aventis NDA for d...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Recommendations for Clinical Laboratory Improvement Amendmen...