YAMA'S LEA'S SHIELD FEMALE BARRIER CONTRACEPTIVE NEEDS 200-PATIENT STUDY, FDA PANEL FINDS; EXISTING DATA INSUFFICIENT TO ESTABLISH PREGNANCY RATE
This article was originally published in The Gray Sheet
Executive Summary
Yama's Lea's Shield silicone vaginal barrier contraceptive device should be evaluated in a study of at least 200 subjects, FDA's Obstetrics and Gynecology Devices Panel concluded at its Oct. 21 meeting in Rockville, Maryland.