HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Floats Broader Pathway For Nicotine Replacement Therapies

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s report to Congress on tobacco abstinence therapy points toward a “comprehensive strategy” for tobacco and nicotine product regulation, incorporating the work of the drug, device and tobacco centers. Some smoking cessation experts say changes are overdue.

You may also be interested in...



US Has Pieces For Solving Policy Puzzle To Spur Spread Of Smoking Cessation Products, Programs

Former FDA tobacco programs chief Mitch Zeller says needed is commitment from White House to require reduction in nicotine levels in tobacco products and movement by FDA on finalizing rules prohibiting use of menthol and other flavors in cigarettes and some cigars.

U.K. Packages All Electronic Cigarettes Under Medical Regulation

The U.K. pharma regulator requires all electronic cigarettes to be licensed as nonprescription medicines beginning in 2016, noting concerns about product quality. Meanwhile, FDA considers allowing e-cigarettes to be marketed as nicotine replacement therapy on a case-by-case basis.

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.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

RS124476

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