Regenerative Medicine Advanced Therapy (RMAT) | PharmaBharat Tools

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Regenerative Medicine Advanced Therapy (RMAT) | PharmaBharat Tools

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RA Expedited & Special ProgramsRegenerative Medicine Advanced Therapy

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Priority Review Voucher (PRV)Rolling Review

Regenerative Medicine Advanced Therapy(RMAT)

Expedited & Special Programs

Definition

An FDA designation for certain regenerative medicine therapies that treat serious conditions and have preliminary clinical evidence indicating potential to address unmet medical needs.

Regulatory source

FDA RMAT program; FD&C Act 506(g)