Thermal endometrial ablation data requirements for amenorrhea claim slated for panel review Jan. 27.
This article was originally published in The Gray Sheet
Executive Summary
THERMAL ENDOMETRIAL ABLATION DATA REQUIREMENTS FOR AMENORRHEA INDICATION will be discussed by FDA's Obstetrics and Gynecology Devices Panel on Jan. 27, beginning at 12:30 p.m. at FDA's Corporate Building. On Jan. 29, the panel will review a product development protocol in closed session.
You may also be interested in...
CryoGen On Track For Second Quarter Endometrial Ablation PMA Submission
Cryogen plans to file data in support of a premarket approval application during the second quarter to expand labeling for the First Option intrauterine cryosurgical probe to include specific references to endometrial ablation as a treatment for dysfunctional uterine bleeding.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.