Overviews and analysis of the U.S. FDA’ s new approvals in the first half year of 2016
10.13220/j.cnki.jipr.2016.04.036
- 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(4):774-784
- CountryChina
- Language:Chinese
-
Abstract:
In the first half year of 2016, the U.S. food and drug administration (FDA) approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes 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 critical events in the history of new drug development and reaserch are emphasized.
