[ Price : $8.95]
FDA closes its post-approval study requirements for Abiomed PMAs for its Impella heart pumps after reviewing favorable performance...[ Price : $8.95]
PhRMA raises issues about the CDER Quality Management Maturity and Knowledge-Aided Assessment and Structured Application programs ...[ Price : $8.95]
FDA launches its Advancing Real-World Evidence Program intended to improve the quality and acceptability of real-world evidence ap...[ Price : $8.95]
Federal Register notice: FDA announces that it is continuing a meeting program to advance the use of complex adaptive, Bayesian, a...[ Price : $8.95]
PTC Therapeutics says enrollment in its Phase 2 Huntingdons disease trial has been paused in the U.S. due to an FDA request for ad...[ Price : $8.95]
FDA says the 8/2 Philips Respironics recall of certain BiPAP and CPAP masks is Class 1.[ Price : $8.95]
FDA posts frequently asked questions on UDI enforcement policy that changes with devices labeled on or after 9/24/23.[ Price : $8.95]
An FDA advisory committee votes 14 to 1 to recommend the market withdrawal of Covis Makena (hydroxyprogesterone caproate injection...