Smoking cessation efficacy requirement reconsidered by FDA advisory committee.
This article was originally published in The Tan Sheet
Executive Summary
SMOKING CESSATION PRODUCT 28-DAY QUIT RATE STANDARD MAY BE INADEQUATE, members of FDA's Drug Abuse Advisory Committee acknowledged at their Feb. 10 meeting on the status of New Life Health Products' silver acetate-containing Quit lozenges. Committee member Alice Young, PhD, Wayne State University, said she would "encourage" the committee, "instead of looking at 28-day smoking cessation," to consider the "possibility of looking at the reduction in the number of cigarettes consumed per day...and/or the reduction in the number of days in which cigarettes were smoked as potential measures...for the evaluation of the usefulness of the product."