INTERACT Meetings (Initial Targeted Engagement for Regulatory Advice on CBER products)

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Drug Development Advice Early Access Support Regulatory Advice Regulatory Affairs Scientific Advice Targeted Engagement for Regulatory Advice

Through a CBER Initial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting, sponsors can obtain initial, nonbinding advice from FDA regarding chemistry, manufacturing and controls, pharmacology/Toxicology, and/or clinical aspects of the development program

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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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INTERACT Meetings (Initial Targeted Engagement for Regulatory Advice on CBER products)