New drugs approved by the U.S. FDA (2007-2016): A review
10.13220/j.cnki.jipr.2016.06.001
- 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(6):1009-1030
- CountryChina
- Language:Chinese
-
Abstract:
The introductions of the new drugs approved by the U.S. FDA have been published in the“ Journal of International Pharmaceutical Research ”for ten years. However, new problems might emerge with the increasing clinical practice and the cumulative number of patients being treated, such as the indications and purposes change, supplement of the modified efficacy, clinical data and the important new indications, constant improvement of the dosage, form and mode of administration, and the emergence of new, serious and even fatal adverse reactions urge the supplements of contraindications, warnings and precautions, or even the black box warnings. In brief, 6 entries of the introductions all may be modified, supplemented or canceled. More importantly, ten years of general analyses also find some prominent events, such as the amount of new molecular entity (NME)and new biological products come to an obvious peak in 2015. With regard to this, this paper reviewed the prominent historical events happened in the ten years in order to provide guidance and reference for new drug research and development.
