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US Orphan Drug Designation

Published by IRDiRC

Early Access Support Orphan Drug Designation Orphan Drug Incentive Regulatory Advice Regulatory Affairs

The ODA is intended to provide incentives for Orphan Drug development and to defray the costs of qualified clinical testing expenses incurred in connection with the development of drugs for rare diseases and conditions.

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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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US Orphan Drug Designation

Rare Pediatric Disease Designation