Advisory Committee On NRT Indications Appears Likely Following Workshop
This article was originally published in The Tan Sheet
Executive Summary
Speakers at a workshop on nicotine-replacement therapy point abroad for guidance on expanding indications for smoking-cessation products as an FDA official says the agency likely will put the question before an advisory committee.
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FDA Delves Into Broader Smoking Cessation Approach
FDA’s notice for a public hearing on smoking cessation approaches suggest a willingness to take an expanded approach to nicotine replacement therapy approvals and indications. Discussion topics include fast-track and accelerated approval authorities for NRTs and extended use of the products.
FDA Delves Into Broader Smoking Cessation Approach
FDA’s questions for comments in a notice for a public hearing on smoking cessation approaches suggest a willingness to take an expanded approach to nicotine replacement therapy approvals and indications. Discussion topics include fast-track and accelerated approval authorities for NRTs and extended use of the products.