FDA Previews Final Drug-Eluting Stent Guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA previewed several changes it will make in its final drug-eluting stent guidance at the Transcatheter Cardiovascular Therapeutics symposium in Washington, D.C., on Oct. 15
You may also be interested in...
Pre-Clinical Testing Issues Spark Questions From DES Manufacturers
Manufacturers' comments and questions about FDA's proposed drug-eluting stent guidance are so far mainly focused on bench and animal testing issues, rather than clinical trials
FDA Pushes Faster Post-Approval Study Starts In Drug-Eluting Stent Guidance
FDA's March 26 1draft guidance on nonclinical and clinical studies of drug-eluting coronary stents is the first device guidance to recommend that sponsors begin post-market studies before their device is approved
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.