Discovering New Therapeutics Uses for Existing Molecules (NTU) program, National Center for Advancing Translational Sciences (NCATS)

Published by IRDiRC

Orphan DrugDrug RepurposingNCATSResearch and Drug DiscoveryNTU-NCATSFunding

The NTU program aims to improve the process of developing new treatments for diseases by finding new uses for existing therapies that already have cleared several key steps along the development path. Existing or partially developed therapeutic candidates can be repurposed for use in new disease indications

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Regenerative Medicine Advanced Therapy (RMAT) Designation

Published by IRDiRC

Regulatory AffairsEarly Access SupportAdvanced TherapyRegenerative Medicine Advanced Therapy Designation

The RMAT Designation is analogous to the Breakthrough Designation designed for traditional drug candidates but applies to regenerative medicine treatments, and allows companies to interact with the FDA more frequently during the clinical development of the therapy. An RMAT-designated therapy is eligible for priority review and accelerated approval.

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