FDA Expedited Program for serious conditions – Breakthrough Therapy Designation

Published by IRDiRC

Regulatory AdviceExpedited ProgrammeBreakthrough Therapy DesignationRegulatory AffairsEarly Access Support

Process designed to facilitate the development and expedite the review of drugs intended to treat a serious condition AND preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

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