FDA Expedited Program for serious conditions – Breakthrough Therapy Designation

Published by IRDiRC

Regulatory AffairsEarly Access SupportRegulatory AdviceExpedited ProgrammeBreakthrough Therapy Designation

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

Published by IRDiRC

Regulatory AffairsEarly Access SupportScientific AdviceRegulatory AdviceTargeted Engagement for Regulatory AdviceDrug Development 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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Interaction of the stakeholders and multilateral education at an early stage of development will facilitate drug development (e.g. ensuring outcome measures for clinical trials are developed that are meaningful for patients, are acceptable to the regulators, and are acceptable to payers)

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