US Expanded Access Program

Published by IRDiRC

Early Access Support Expanded Accesss Programme Orphan Drug Orphan Medicine Regulatory Affairs Research and Drug Development

The Program allows patients with serious rare diseases to have access to pre-market drugs and devices, if the Sponsor agrees to this under their expanded access policy

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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 Expanded Access Program