THERMAL ENDOMETRIAL ABLATION GUIDANCE SHOULD RETAIN ONE-YEAR FOLLOW-UP FOR MOST PATIENTS, PANEL ADVISES FDA; REVISED GUIDANCE IN DOCUMENT DEVELOPMENT
This article was originally published in The Gray Sheet
Six-month premarket clinical follow-up is acceptable for thermal endometrial ablation patients who did not receive drug therapy prior to treatment, but one-year follow-up still is preferable for the majority of subjects in trials for new ablation devices, members of FDA's Obstetrics and Gynecology Panel agreed at a Jan. 27 meeting in Rockville, Maryland.
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