The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.'' The document provides guidance regarding the nonclinical information FDA recommends to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and other chronic uses.
Document
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonclinical Testing of Orally Inhaled Nicotine-Contai...
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83 FR 38315
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“Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products; Draft Guidance for Industry; Availability,” thefederalregister.org (August 6, 2018), https://thefederalregister.org/documents/2018-16726/nonclinical-testing-of-orally-inhaled-nicotine-containing-drug-products-draft-guidance-for-industry-availability.