Approval of new drugs in the United States - Comparison with the United Kingdom, Germany, and Japan

被引：28

作者：

Kessler, DA

Hass, AE

Feiden, KL

Lumpkin, M

Temple, R

机构：

[1] US FDA, OFF PLANNING & EVALUAT, ROCKVILLE, MD 20857 USA

[2] US FDA, CTR DRUG EVALUAT & RES, ROCKVILLE, MD 20857 USA

来源：

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 1996年 / 276卷 / 22期

关键词：

D O I：

10.1001/jama.276.22.1826

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

In a study reported herein, the marketing approval dates of 214 drugs newly introduced into the world market from January 1990 through December 1994 were compared in 4 countries. The analysis reveals that the United States and the United Kingdom have similar patterns of drug availability, although the United States has a number of therapies with significant public health benefits that are not yet available in the United Kingdom. The findings also show that the United States outpaces both Germany and Japan in approving important new drugs. Various strategies adopted by the Food and Drug Administration to expedite its pharmaceutical review process, including the use of industry user fees, are described.

引用

页码：1826 / 1831

页数：6