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Nicotine replacement secondary outcomes should be included in labeling -- cmte. chair.

This article was originally published in The Tan Sheet

Executive Summary

NICOTINE REPLACEMENT LABELING SECONDARY OUTCOME MEASURES INCLUSION would be a "good" addition, FDA Drug Abuse Advisory Committee Chairman Eric Strain, MD, Johns Hopkins Bayview Medical Center, suggested at a June 9 meeting of the committee in Bethesda, Md. The committee, with representation from the Nonprescription Drugs Advisory Committee, met to discuss whether smoking cessation product labeling might be expanded to include data on "secondary outcome" measures, such as: the number of people who are able to quit smoking using the product despite relapses; the fraction of study participants successful long term (six months or one year after treatment); or other benefits, such as reduction in withdrawal symptoms or overall number of cigarettes smoked.
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