Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program

CONTEXT: In 1997, Congress authorized the 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 chi...

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Main 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.
Format: Artigo
Sprog:Inglês
Udgivet: 2007
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Article
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC2773665/
https://ncbi.nlm.nih.gov/pubmed/17284698
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.297.5.480
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