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- Title
Economic return of clinical trials performed under the pediatric exclusivity program.
- Authors
Li, Jennifer S; Eisenstein, Eric L; Grabowski, Henry G; Reid, Elizabeth D; Mangum, Barry; Schulman, Kevin A; Goldsmith, John V; Murphy, M Dianne; Califf, Robert M; Benjamin, Daniel K, Jr
- Abstract
In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been praised for creating incentives for studies in children and has been criticized as a "windfall" to the innovator drug industry. This critique has been a substantial part of congressional debate on the program, which is due to expire in 2007.
- Publication
JAMA, 2007, Vol 297, Issue 5, p480
- ISSN
1538-3598
- Publication type
Journal Article
- DOI
10.1001/jama.297.5.480