History of Orphan Drug Regulation-United States and Beyond

被引：21

作者：

Haffner, M. E. ^{[1
]}

机构：

[1] Haffner Associates LLC, Rockville, MD 20852 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2016年 / 100卷 / 04期

关键词：

D O I：

10.1002/cpt.426

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The US Orphan Drug Act, passed in 1982, was the first orphan drug legislation in the world. It is a law based on economic incentives making it financially possible for pharmaceutical firms to develop products for small patient populations. Since passage, many additional countries have developed orphan drug programs and many pharmaceutical firms have developed around the orphan program. Today, more than 500 drugs for rare diseases have been developed in the United States.

引用

页码：342 / 343

页数：2