Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts