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- [1] 1993, OTAH522 OFF TECHN AS
US DRUG AND BIOLOGIC PRODUCT APPROVALS DURING 1993
被引：0
作者：
BEARY, JF
EATEN, CR
COPMANN, TL
WIERENGA, DE
机构：
[1] Division of Science and Technology, Pharmaceutical Research and Manufacturers of America, Washington, District of Columbia
关键词：
NEW DRUGS;
1993;
NEW DRUG APPLICATION REVIEW PROCESS;
D O I：
10.1002/ddr.430320302
中图分类号：
R914 [药物化学];
学科分类号：
100701 ;
摘要：
Drugs remain a key element in the effective containment of health care costs. In 1993, 29 new drugs were approved for marketing by the US Food and Drug Administration (FDA). These entities, according to a 1993 Office of Technology Assessment study, each took on average 12 years and $359 million each to discover and develop. The FDA reported that the average review time for these entities was 26.5 months, some 3 months less than reported in 1992. Under the prescription Drug User Fee Act of 1992, which will generate an additional $327 million over the period 1993-1997, the FDA will hire an additional 600 review staff. (C) 1994 Wiley-Liss, Inc.
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页码：127 / 133
页数：7
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