Overviews and analysis of the U.S. FDA′s new approvals in the 2015 second half year
10.13220/j.cnki.jipr.2016.01.026
- Author:
Zhong-Ming TANG
1
Author Information
1. Institute of Radiation Medicine, Academy of Military Medical Sciences
- Publication Type:Journal Article
- Keywords:
Adverse reactions;
Chemical structure;
Indications;
Mechanism;
New biological products;
New drug approval;
New molecular entity;
The U.S. FDA
- From:
Journal of International Pharmaceutical Research
2016;43(1):167-178
- CountryChina
- Language:Chinese
-
Abstract:
In the second half year of 2015, the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti-ties single or compounds and 15 biologics license applications, a total of 35 which record number of approved innovative drugs. Ac-cording to the prescription information for professionals, this article briefly describes the description, mechanism of action and clinical studies, the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and criti-cal events in the history of new drug development and reaserch are emphasized.
