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

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.

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Bibliographic Details
Published inThe New England journal of medicine Vol. 377; no. 23; pp. 2278 - 2286
Main Authors Darrow, Jonathan J, Avorn, Jerry, Kesselheim, Aaron S
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 07.12.2017
Subjects
Biological products
Clinical trials
Drug Approval - economics
Drug Approval - legislation & jurisprudence
Drug Industry - economics
Drug Industry - legislation & jurisprudence
FDA approval
Federal legislation
Fees & charges
Funding
Health Policy
History, 20th Century
History, 21st Century
Pharmaceutical industry
Prescription drugs
United States
United States Food and Drug Administration - economics
United States Food and Drug Administration - history
United States Food and Drug Administration - legislation & jurisprudence
User fees
United States > US
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Summary: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.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMhle1710706