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Pages 1-6

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From page 1...
... The limited amount of testing of drugs in pediatric patients is reflected in the lack of pediatric-specific information on the product labels for many drugs used to treat children. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence.
From page 2...
... , the National Institutes of Health, the American Academy of Pediatrics, the pharmaceutical industry, academia, and several patient advocacy groups to discuss • the current regulatory framework, • current challenges in prescribing and developing drugs for children, • models for enhancing pediatric drug development, and • challenges and opportunities for the future. REGULATORY FRAMEWORK Regulatory efforts to protect children from harmful medications began in the early part of the twentieth century.
From page 3...
... Barriers to the development of medications for children were discussed, including ethical, economic, logistical and technical barriers, as well as the industry perspective of these barriers. Ethical barriers cited include clinicians who prescribe drugs off label absent sufficient pediatric data, which results in delays in needed research; drug sponsors who pursue pediatric clinical trials late in a drug's life cycle, with more objectives and procedures included than may be appropriate for the study design; academic institutions that fail to reward investigators for participating in clinical trials; and a clinical research enterprise that lacks transparency at all levels.
From page 4...
... MODELS FOR ENHANCING PEDIATRIC DRUG DEVELOPMENT Workshop participants cited creative solutions from the vaccine development arena that might be applied to pediatric drugs: the no-fault compensation system for patients (or their families) who suffer serious adverse reactions from required childhood vaccines, and the two-page public information fact sheets on each vaccine.
From page 5...
... vaccine development, European Union regulations, and St. Jude's efforts to develop public–private partnerships for the discovery and development of pediatric cancer drugs.


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