AdvaMed and other industry groups comment on FDAs recent draft guidance on The Special 510(k) Program, suggesting that the documents proposed text may...
FDA approves a Medifocus PMA supplement for new labeling for its Prolieve Transurethral ThermoDilatation Therapy based on the results from the company...
Federal Register notice: FDA seeks comments on an information collection extension entitled: Oversight of Clinical Investigations: A Risk-Based Approa...
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...