Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels
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Susan K. McCmne, MD Medical Officel; Division of Pediatric Drug Development, Center for Drug Evaluation and Research, Food and Drug Administration. Rockville, Maryland Lisa 1. Mathis, MD Acting Director. Division of Pediatric Drug Development. Center for Drug Evaluation and Research, Food and Drug Administration. Rockville. Maryland David M. Coccbetto, PhD, RPb U S Regulatory Affairs, GlaxoSmithKline, Research Triangle Park, North Carolina Karen Ball, BS President and CEO, The SturgeWeber Foundation. Freedom, New Jersey W. Rodriguez, MD, PhD Science Director for Pediatrics, Office of Counter-terrorism and Pediatric Drug Development, Center for Drug Evaluation and Research. Food and Drug Administration. Rockville, Maryland
Key Words Pediatric drug development; Global partnership in drug development; Clinical trial design; Pediatric regulatory issues; Offlabel use of drugs Correipondente Address William Rodriguez. MD. PhD, Food and Drug Administration. Center for Drug Evaluation and Research, Office of Counter-teworism and Pediatric Drug Development (OCTAP). 10903 New Hampshire Avenue, Silver Spring, M D 20993 (e-mail: [email protected]). Presented in part at DIA 4 l s t Annual Meeting. June 26-30, 2005, in Washington. DC.
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The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Drug Information Association designates this educational activity for a maximum of 1 category I credit toward the AMA Physician's Recognition Award. Each physician should only claim those credits that he/she actually spent in the activity. lfyou would like to receive a statement of credit,you must review the article. answer the questions to the posttest on the Post-test and Evaluation Form and submit it to the DIA. Participants must receive a passing score of 80% or better on the post-test in order to receive a statement of credit. Statements of credit will be mailed within one month of receipt of the Post-test and Evaluation Form. There is no fee to receiveyour statement of credit. Release Date: May 2006 Expiration Date: May 31, 2007 Estimated time to complete the activity: I hour
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Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels Off-labeluse of drugs in pediatrics remains a national and internationalproblem. 2'keAmerican Academy of Pediatrics determined in l977 and reafirmed in 1995, that there was a moral imperative toformally study drugs in children so they "have access to important medications and receive optimal drug therapy " Congress passed legislation in 1997that encouraged the study of patent drugs, or those with remaining exclusivity or patent protection, in pediatric patients. Manufacturers of new chemical entities could earn an incentive (in theform ofpediatric exclusivity) for their product ifa program of pediatric clinical research that met the requirements of a Written Request from the Food and Drug Administration was completed as scheduled. Such pediatric research must
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