Overviews and analysis of the U.S. FDA′s new approvals in the 2016 second half year
10.13220/j.cnki.jipr.2017.01.013
- VernacularTitle:2016年下半年美国FDA批准药物简介
- Author:
Zhongming TANG
- Keywords:
new drug approval;
the U.S. FDA;
new molecular entity;
new biological products;
chemical structure;
mecha-nism;
indications;
adverse reactions
- From:
Journal of International Pharmaceutical Research
2017;44(1):74-80
- CountryChina
- 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.
