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- Title
New "21st Century Cures" Legislation: Speed and Ease vs Science.
- Authors
Kesselheim, Aaron S.; Avorn, Jerry
- Abstract
The author discusses the December 2016 passing of the 21st Century Cures Act to increase the speed and ease of drug development. Topics include the Act's recommendation for annual increases to the National Institutes of Health budget, restrictions to the types of data manufacturers can use to gain the U.S. Food & Drug Administration's (FDA's) approval, and the FDA's development of guidance on the uses of real-world evidence drawn from health care claims data.
- Subjects
UNITED States; DRUG laws; DRUG development; NATIONAL Institutes of Health (U.S.); UNITED States. Food &; Drug Administration; HEALTH insurance claims; FINANCE; BUDGET laws; DRUG approval laws; GOVERNMENT aid laws; INDUSTRIES; COMPARATIVE studies; ENDOWMENT of research; RESEARCH methodology; MEDICAL cooperation; PRACTICAL politics; RESEARCH; SCIENCE; EVALUATION research; ECONOMICS; STANDARDS; LAW
- Publication
JAMA: Journal of the American Medical Association, 2017, Vol 317, Issue 6, p581
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2016.20640