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Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products; Guidance for Industry; Availability
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Zusammenfassung
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 This guidance finalizes the draft guidance of the same name issued August 6, 2018.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →