Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI

被引：39

作者：

Darrow, Jonathan J. ^{[1
]}

Avorn, Jerry

Kesselheim, Aaron S.

机构：

[1] Brigham & Womens Hosp, Dept Med, Program Regulat Therapeut & Law PORTAL, Div Pharmacoepidemiol & Pharmacoecon, 75 Francis St, Boston, MA 02115 USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2017年 / 377卷 / 23期

关键词：

CLINICAL DEVELOPMENT; SURVIVAL; APPROVAL; DRUGS; RISK; ACT;

D O I：

10.1056/NEJMhle1710706

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The FDA Reauthorization Act of 2017 includes the sixth version of the Prescription Drug User Fee Act. User fees have accelerated drug approvals in the context of inadequate funding of the FDA, and industry now pays 75% of the costs of the scientific review of drugs. © Copyright 2017 Massachusetts Medical Society.

引用

页码：2278 / 2286

页数：9

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