THERMAL ENDOMETRIAL ABLATION QUALITY OF LIFE DATA COULD BE "KEY" TO PMA APPROVAL, PANEL AGREES; RANDOMIZED EFFICACY STUDY DESIGN ALSO ENDORSED
This article was originally published in The Gray Sheet
Executive Summary
Quality of life improvements can outweigh less-than-optimal clinical effectiveness results in the approval of thermal endometrial ablation devices, members of FDA's Obstetrics and Gynecology Advisory Panel said at an Oct. 24 meeting in Rockville, Maryland.