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GUIDANCE DOCUMENT

Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products May 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2019-D-0297
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Smoking Cessation and Related Indications:  Developing Nicotine Replacement Therapy Drug Products; Guidance for Industry.”  The document provides guidance to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products, including but not limited to those intended for smoking cessation and related chronic indications.  This guidance finalizes the draft guidance of the same title issued on February 22, 2019.

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All written comments should be identified with this document's docket number: FDA-2019-D-0297.

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