Nonclinical testing of orally inhaled nicotine-containing drug products

Nonclinical testing of orally inhaled nicotine-containing drug products

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Language(s):
English
Format:
Text
Subject(s):
Administration, Inhalation
Tobacco Use Cessation Devices
Toxicity Tests
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance provides sponsors with recommendations on the nonclinical information to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications. This guidance focuses on novel chemicals of the drug product formulation, novel chemicals generated from any chemical of the drug product formulation by the delivery system (e.g., heatgenerated chemicals), and novel impurities from the drug product formulation and delivery system. This guidance does not address nonclinical toxicity studies that may be requested by the Center for Devices and Radiological Health to support use of the delivery system (e.g., biocompatibility studies).
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (10 pages)).
NLM Unique ID:
9918248909706676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918248909706676