Table 2.

FDA Designations to Accelerate Drug Development Times

Designation	Year/Legislation	Criteria
Accelerated Approval	FDA instituted in 1992, but legislation in 2012 (FDASIA) allowed use of surrogate endpoints.	DAB that treats a serious condition∗ that fills an unmet medical need can be approved on the basis of a surrogate endpoint: for example, lab marker, radiographic images, physical sign, or other finding that is thought to predict clinical benefit. Surrogate or intermediate clinical endpoints are allowed.
Priority Review	1992 PDUFA	DAB would be a significant improvement in the safety or efficacy of the treatment, diagnosis, or prevention of serious conditions when compared to standard therapy.
Fast Track	FDA Modernization Act of 1997	DABs that treat a serious condition must fulfill an unmet medical need or provide therapy that is substantially better in safety and efficacy than existing ones. Fast-Track DABs may also be eligible for Accelerated Approval and Priority Review if criteria are met,
Breakthrough Therapy	2012 FDASIA	DABs that are intended to treat a serious condition, and preliminary clinical evidence indicates that it may demonstrated substantial improvement over available therapy on a clinically significant endpoint. Surrogate endpoints allowed.
Regenerative Medicine Advanced Therapy	21st Century Cures Act, 2016	Regenerative medicine advanced therapy (cell therapy therapeutic tissue engineering product, human cell and tissue product, or any combination product using these) used to treat, modify, reverse, or cure a serious or life-threatening condition, and preliminary clinical evidence indicates that it has the potential to address an unmet medical need

DAB = Drugs and Biologics; FDASIA = U.S. Food and Drug Administration Safety Innovations Act; other abbreviations as in Table 1.

^∗The FDA defines a serious condition as one that will have an impact on day-to-day survival, functioning or the likelihood that if left untreated a condition will progress from a less serious one to a serious one.