FDA Fast Track Designation

Fast Track designation is an FDA program that facilitates the development and expedites the review of a drug intended to treat a serious or life-threatening condition, when nonclinical or clinical data demonstrate the drug’s potential to address an unmet medical need. Created by the FDA Modernization Act of 1997 and codified at Section 506(b) of the Federal Food, Drug, and Cosmetic Act, it is the entry-level tier of FDA’s four expedited programs for serious conditions — alongside Breakthrough Therapy designation, which requires a higher bar of preliminary clinical evidence; Accelerated Approval, an approval pathway built around surrogate endpoints; and Priority Review, which shortens FDA’s own review clock. See the FDA Expedited Programs guide for how all four fit together.

Last verified August 25, 2026 against FDA’s “Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review” overview and its dedicated Fast Track page.

Qualifying Criteria

Section 506(b) of the FD&C Act provides for fast track designation of a drug “… if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.” That is two conjunctive elements a sponsor has to satisfy.

1. Serious condition

FDA treats “serious” as a matter of judgment based on a condition’s impact on survival, day-to-day functioning, or its likelihood of progressing from a less severe state to a more serious one if left untreated. FDA’s own examples include AIDS, Alzheimer’s disease, heart failure, and cancer — but also epilepsy, depression, and diabetes.

2. Potential to address unmet medical need

Filling an unmet medical need means providing a therapy where none currently exists, or one that may work better than what is already available — for example, by showing superior effectiveness, avoiding a serious side effect of an existing therapy, improving diagnosis where earlier diagnosis improves outcomes, decreasing a clinically significant toxicity that causes patients to discontinue an available treatment, or addressing an emerging or anticipated public health need. The evidence FDA expects varies with the stage of development: early on, nonclinical data, a mechanistic rationale, or pharmacologic data can support a request; later in development, available clinical data should demonstrate the potential.

What Fast Track Designation Grants

A drug that receives Fast Track designation is eligible for some or all of the following, per FDA:

More frequent meetings with FDA to discuss the development plan and the data needed to support approval, including pre-IND, end-of-phase-1, and end-of-phase-2 meetings.
More frequent written communication from FDA on matters such as clinical trial design and the use of biomarkers.
Eligibility for Accelerated Approval and Priority Review, if the drug separately meets the relevant criteria for each — Fast Track designation does not itself confer either.
Rolling Review — a sponsor can submit completed sections of a Biologics License Application (BLA) or New Drug Application (NDA) for FDA review as they are finished, rather than waiting until the entire application is complete. BLA or NDA review ordinarily does not begin until the sponsor has submitted the full application, so this is a meaningful procedural shortcut for a fast track product.

Requesting and Keeping the Designation

Fast Track designation must be requested by the drug’s sponsor — unlike Priority Review, FDA does not assign it on its own initiative. A request can be made when the Investigational New Drug (IND) application is first submitted, or at any time afterward, under section 505(i) or section 351(a)(3) of the Public Health Service Act. FDA reviews the request and responds within 60 calendar days, based on whether the drug fills an unmet medical need for a serious condition.

Designation is not permanent. FDA guidance notes that a fast track development program can stop meeting the qualifying criteria as it progresses — for instance, if emerging clinical data fail to show the anticipated advantage over available therapy — and FDA can rescind the designation once it is no longer supported by the evidence.

Fast Track vs. Breakthrough Therapy, Accelerated Approval, and Priority Review

All four programs address serious or life-threatening conditions, but each intervenes at a different point in development or review, and each rests on its own legal basis:

	Fast Track	Breakthrough Therapy	Accelerated Approval	Priority Review
Legal basis	Section 506(b), FD&C Act — added by the FDA Modernization Act of 1997, amended by FDASIA (2012)	Section 506(a), FD&C Act — added by FDASIA (2012)	Section 506(c), FD&C Act, as amended by FDASIA (2012); 21 CFR part 314 subpart H / part 601 subpart E	Prescription Drug User Fee Act of 1992 (PDUFA)
Qualifying criteria	Serious condition AND nonclinical or clinical data show potential to address unmet medical need	Serious condition AND preliminary clinical evidence of substantial improvement over available therapy on a clinically significant endpoint	Serious condition AND a meaningful advantage over available therapies AND an effect on a surrogate or intermediate clinical endpoint reasonably likely to predict clinical benefit	An application that, if approved, would be a significant improvement in safety or effectiveness for a serious condition
What it acts on	Frequency of FDA interaction during development; eligibility for Rolling Review	Everything Fast Track offers, plus intensive FDA guidance across the whole development program and organizational commitment from FDA	The evidentiary basis for approval itself — a surrogate or intermediate endpoint instead of a direct outcome measure — with confirmatory trials required afterward	FDA’s own review clock for a completed application: 6 months instead of the standard 10
Who initiates it	Sponsor requests; FDA responds within 60 days	Sponsor requests, ideally by the end-of-phase-2 meeting; FDA responds within 60 days	Sponsor discusses with the review division during development	Determined by FDA’s review division at the time the application is filed

Fast Track is generally the easiest of the four to qualify for, since it needs only nonclinical or clinical evidence of potential rather than proof of an actual treatment effect — which is why sponsors often obtain it first and pursue the others as stronger data accumulates over the course of development.

Why This Matters for Research Administration

For research administrators and clinical trial operations staff, Fast Track designation is usually the earliest signal that a sponsor’s development timeline may compress: the more frequent FDA meetings a designated program receives can translate into faster protocol amendments, revised enrollment targets, or accelerated site-activation timelines relative to a conventional program. Because eligibility for Rolling Review lets a sponsor submit application sections as they are completed rather than all at once, an institution supporting a Fast Track program may also see submission-related data requests arrive on a different cadence than the single end-of-study package a standard program produces. None of this changes the underlying trial-conduct obligations a site is held to — Fast Track designation changes how closely and how early FDA engages with the sponsor, not the evidentiary or ethical standards the trial itself must meet.

Frequently Asked Questions

What is the legal basis for FDA Fast Track designation?

Fast Track designation is provided for at Section 506(b) of the Federal Food, Drug, and Cosmetic Act, added by the FDA Modernization Act of 1997 (FDAMA) and later amended by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA).

What is the difference between Fast Track and Breakthrough Therapy designation?

Fast Track requires only that nonclinical or clinical data show the drug’s potential to address an unmet medical need for a serious condition. Breakthrough Therapy designation requires everything Fast Track requires, plus preliminary clinical evidence that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint — a materially higher evidentiary bar.

Does Fast Track designation guarantee faster approval?

No. It does not change the evidentiary standard a marketing application must meet, and it does not itself confer Accelerated Approval or Priority Review — a fast track product only becomes eligible for those if it separately meets each program’s own criteria. What Fast Track changes is how frequently and how early FDA engages with the sponsor’s development plan.

What is Rolling Review?

Rolling Review is a feature available to a fast track product in which a sponsor can submit completed sections of its BLA or NDA for FDA review as they are finished, instead of waiting to submit the complete application at once. Ordinarily, FDA review does not begin until a sponsor has submitted the entire application.

How long does FDA take to decide on a Fast Track designation request?

FDA reviews a fast track designation request and responds within 60 calendar days of receipt.

Can FDA withdraw Fast Track designation once granted?

Yes. If a development program stops meeting the qualifying criteria — for example, if emerging clinical data no longer support the drug’s potential advantage over available therapy — FDA can rescind the designation.