Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products." The document provides guidance about 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 related chronic indications. This guidance finalizes the draft guidance of the same name issued August 6, 2018.