Journal of International Pharmaceutical Research 2017;44(1):74-80

doi:10.13220/j.cnki.jipr.2017.01.013

Overviews and analysis of the U.S. FDA′s new approvals in the 2016 second half year

Zhongming TANG

Keywords

new drug approval; the U.S. FDA; new molecular entity; new biological products; chemical structure; mecha-nism; indications; adverse reactions

Country

China

Language

Chinese

Abstract

In the second half of 2016,the U.S. Food and Drug Administration(FDA)approved 7 new molecular entities and 3 new Biologic License Application(BLA), the lowest number in recent years. According to the prescription information for profes-sionals,this article introduced the description,mechanism of action and clinical studies and briefly describes the boxed warning,indi-cations and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reac-tions,drug interaction and the use in the special population. In addition,the first and critical events in the history of new drug develop-ment and reaserch were emphasized.