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

UsernamePublicRestriction
UsernamePublicRestriction

NRT Petition Calls On FDA To Greatly Expand Indications, Availability

This article was originally published in The Tan Sheet

Executive Summary

FDA's stated commitment to a public health approach to drug regulation will be put to the test by a petition to expand nicotine replacement therapy indications and availability

You may also be interested in...



Smoking Cessation Label Changes Could Lay Groundwork For Indications

FDA drops its requirement for labeling provisions for NRTs on duration of use and concomitant use of tobacco or other NRTs. Meanwhile, the agency rejects citizen petition requests for additional NRT indications, but says it is open to working with sponsors on developing those indications.

Smoking Cessation Label Changes Could Lay Groundwork For Indications

FDA drops its requirement for labeling provisions for NRTs on duration of use and concomitant use of tobacco or other NRTs. Meanwhile, the agency rejects citizen petition requests for additional NRT indications, but says it is open to working with sponsors on developing those indications.

FDA Asks For Road Map To Broader NRT Indications

While the agency appears to favor moving to a broad harm reduction framework for indications for NRTs, including lifting limits on recommended duration of use, there remains “a lot of devil in the details” of expanding indications.

Related Content

Topics

UsernamePublicRestriction

Register

OM014142

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel