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Fast Track Designation

Category: Biotech Service

Exhibitor: ONLY ORPHANS COTE LLC

Booth No: L724

Characteristic

The Fast Track Designation is a status granted by the FDA to certain investigational drugs or therapies that aim to treat serious or life-threatening conditions and demonstrate the potential to address an unmet medical need. The Fast Track designation was established to expedite the development, review, and approval of these promising therapies to benefit patients with urgent medical needs. The benefits include expedited development and Review, priority review and enhanced FDA interaction.

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