GUIDANCE DOCUMENT
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products February 2019
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2019-D-0297
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.” 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.
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All written comments should be identified with this document's docket number: FDA-2019-D-0297.