Science Translational Medicine · 2011 · 23 citations · 7 references
PharmacyPediatricsPharmaceutical PolicyPediatric TherapeuticsBenefit-risk AssessmentChild Health FinancingChild Health SubsidiesHope ValuePediatric Drug ApprovalPediatric Drug DevelopmentPharmaceutical Innovation IncentivesRealized Benefits
Enhancing drug development for pediatric disease is a priority and a public responsibility. The Creating Hope Act of 2010 is important new proposed legislation that adds drugs and biologics for treating rare diseases in children to those for neglected tropical diseases as eligible for a priority review voucher from the U.S. Food and Drug Administration. The Act enhances existing incentive programs through specific financial benefits to companies who seek a pediatric indication for a new drug to treat an orphan disease that occurs specifically in children.
7
Rosemary Roberts, William Rodriguez, Dianne Murphy et al. · JAMA · 2003 · 297 citations
Pharmacy, Pediatrics, Pharmacology +13
Developing Drugs For Developing Countries
David B. Ridley, Henry G. Grabowski, Jeffrey L. Moe · Health Affairs · 2006 · 199 citations · Full text
Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program
Jennifer S. Li, Eric L. Eisenstein, Henry G. Grabowski et al. · JAMA · 2007 · 170 citations · Full text
European perspectives on pediatric formulations
Jörg Breitkreutz · Clinical Therapeutics · 2008 · 66 citations
Pharmacy, Pediatrics, Pharmaceutics +14