Overview and analysis of the U.S. FDA′s new approvals in the second half year of 2014
10.13220/j.cnki.jipr.2015.01.019
- Author:
Zhong-Ming TANG
1
Author Information
1. Institute of Radiation Medicine, Academy of Military Medical Sciences
- Publication Type:Journal Article
- Keywords:
Adverse reactions;
Approval;
Chemical structure;
FDA;
Indications;
Mech-anism;
New biological products;
New drug;
New molecular entity;
The U.S
- From:
Journal of International Pharmaceutical Research
2015;42(1):115-126
- CountryChina
- Language:Chinese
-
Abstract:
In the second half year of 2014, the U.S. Food and Drug Administration (FDA) approved 72 new drugs, including 18 new molecular entities (NME) and 10 new biologic license application. 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.
