Safety Monitoring of Drugs Receiving Pediatric Marketing Exclusivity

OBJECTIVE: The Food and Drug Administration (FDA) Modernization Act provided for an additional 6-month period of marketing exclusivity to companies that perform pediatric drug trials in response to an FDA-issued written request. Because many safety concerns cannot be detected until after the introdu...

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Main Authors: Smith, P. Brian, Benjamin, Daniel K., Murphy, M. Dianne, Johann-Liang, Rosemary, Iyasu, Solomon, Gould, Barbara, Califf, Robert M., Li, Jennifer S., Rodriguez, William
Formato: Artigo
Idioma:Inglês
Publicado: 2008
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Article
Acceso en liña:https://ncbi.nlm.nih.gov/pmc/articles/PMC2561901/
https://ncbi.nlm.nih.gov/pubmed/18762496
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1542/peds.2008-0585
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