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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.
A designation for medicines intended to treat rare diseases/conditions, often providing incentives such as fee reductions and market exclusivity (region-specific).
EMA’s PRIority MEdicines scheme that supports development of medicines addressing unmet medical need through early, enhanced scientific and regulatory support.
An FDA review designation with a shorter target review timeline than standard review, intended for drugs that may provide significant improvements for serious conditions.
A voucher program that can grant priority review for a future application under specific eligibility programs; vouchers may be transferable in some frameworks.
An FDA designation for certain regenerative medicine therapies that treat serious conditions and have preliminary clinical evidence indicating potential to address unmet medical needs.
A regulatory review approach allowing submission of completed sections of an application as they become available, rather than waiting for the entire dossier.
Submission of portions of a dossier as they are completed, typically enabled under specific expedited programs or agreements with regulators.