Addressing the Barriers to Pediatric Drug Development: by Development, and Translation Forum on Drug Discovery, PDF

By Development, and Translation Forum on Drug Discovery, Institute of Medicine

ISBN-10: 0309107423

ISBN-13: 9780309107426

ISBN-10: 0309107431

ISBN-13: 9780309107433

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Two-page public information fact sheets on each vaccine describing benefits and risks, issued by the government and written for the lay public, also stimulate reporting by consumers. In addition, the Vaccine Safety Data Link (VSDL) was established to monitor immunization safety and address gaps in knowledge about rare and serious side effects associated with immunizations. It monitors rates of adverse events from eight managed care organizations that cover roughly 2 percent of the population. VAERS works by identifying signals that indicate there may be a problem, while VSDL is better for assessing causality.

She indicated that she would prefer to see an active surveillance system. The European Union’s New Regulatory Approach Dr. Weyersberg described a new EU regulation on pediatric drug development. The regulation, which entered into force on January 26, 2007, is applicable and obligatory for all 25 EU member states. Its goals include imp����������������������������������������������������������������� roving the health of children by fostering high-quality, ethical research on pediatric medicines; increasing the availability of medicines authorized for children; and expanding the information base on the use of medicines in pediatric populations.

They also stressed the importance of better communication to prescribers and consumers so they will know not only how to deal with adverse events, but also how to use the medications properly. Finally, lessons can be learned from the European Union’s recent regulations, which represent a coordinated effort to improve the study of on-patent, off-patent, and orphan drugs. The compensation fund and information sheets that are integral to vaccine drug development can also serve as models for pediatric drug development.

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Addressing the Barriers to Pediatric Drug Development: Workshop Summary by Development, and Translation Forum on Drug Discovery, Institute of Medicine


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