비즈니스 · 2018. 8. 6.1 분 읽기
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products; Draft Guidance for Industry; Availability
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products."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.