Overviews and analysis to the U. S. FDA's new approvals in 2012
- 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 product;
New drug approval;
New molecular entity;
The U. S. FDA
- From:
Journal of International Pharmaceutical Research
2013;40(1):111-123
- CountryChina
- Language:Chinese
-
Abstract:
In 2012, the U. S. Food and Drug Administration (FDA) approved 34 new drugs, including 23 new molecular enities and 11 new biological products. According to he prescription nformation for professionals, this article briefly describes he description, mechanism of action, the box warning, indications and usage, dosage and administration, dosage form and strength, contrandications, warning and precautions, adverse reactions, drug nteraction and use of these new drugs n special population. In addiion, the first events n he history of new drug research, development and approval are also discussed.