"Creating hope" and other incentives for drug development for children.
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.
Office of Innovation Development and Investigational Therapeutics, Clinical and Translational Science Institute, Children's Research Institute, Children's National Medical Center, Washington, DC 20010, USA. econnor@cnmc.org
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D002648:Child; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D015195:Drug Design; D004345:Drug Industry / Q000191:economics / Q000639:trends*; D006291:Health Policy; D006801:Humans; D058069:Neglected Diseases; D009965:Orphan Drug Production / Q000191:economics / Q000331:legislation & jurisprudence*; D010372:Pediatrics / Q000379:methods; D035583:Rare Diseases / Q000188:drug therapy; D014481:United States; D014486:United States Food and Drug Administration