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FDA Pediatrics Advisory Committee

Published by IRDiRC

Biomedical Ethics Early Access Support Paediatric Medicine Paediatric Regulation Paediatric Research Paedriatic Advisory Committee Regulatory Advice Regulatory Affairs

The Pediatric Advisory Committee (PAC) is a committee of authorities knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics who advise and make recommendations to the FDA

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Rare Pediatric Disease Designation

Published by IRDiRC

Early Access Support Orphan Drug Designation Paediatric Medicine Rare Paediatric Disease Designation Regulatory Affairs

The FDA grants rare pediatric disease designation for diseases with serious or life- threatening conditions that affect people from birth to 18 years of age, that affect fewer than 200,000 people in the U.S.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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FDA Pediatrics Advisory Committee

Rare Pediatric Disease Designation