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Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval, PRIME, and similar pathways
11 terms
An FDA approval pathway for serious conditions allowing approval based on a surrogate or intermediate clinical endpoint, with required post-marketing confirmatory trials.
An FDA program to expedite development and review of drugs that may show substantial improvement over available therapy on clinically significant endpoints.
An EU mechanism allowing early approval on less comprehensive data than normally required when the benefit of immediate availability outweighs the risk, with specific obligations to provide comprehensive data post-authorisation.
An FDA program to facilitate development and expedite review of drugs that treat serious conditions and fill an unmet medical need, often enabling more frequent interactions and potential rolling review.