FDA WOULD EXPEDITE SUPPLEMENTS FOR CLINICAL-EFFECTIVENESS CLAIMS BASED ON STUDIES CONDUCTED UNDER WYDEN BILL TO ENCOURAGE COMPARATIVE EVALUATIONS
This article was originally published in The Gray Sheet
Executive Summary
The latest draft of Rep. Ron Wyden's (D-Ore.) "Partnership for Medical Technology Evaluations" bill would require FDA to expedite review of supplemental device and drug applications for clinical- effectiveness claims based on studies conducted under the aegis of the legislation.