Fast Track Designation

Key facts

Legal basis

Section 506(b) of the FD&C Act

Created by

Food and Drug Administration Modernization Act of 1997

Evidence needed

Nonclinical or clinical data showing potential to meet an unmet need

FDA response time

Within 60 days of receiving the request

Key benefit

Rolling review of completed sections of an NDA or BLA

What is fast track designation?

Fast track is the least demanding of the FDA expedited programs for serious conditions in terms of evidence. A sponsor can qualify early in development, even with nonclinical data, as long as the product has the potential to address an unmet medical need by filling a gap where no therapy exists or improving on existing options.

Like breakthrough therapy designation, fast track does not change the approval standard. It changes the process, and the FDA can withdraw the designation if the product stops meeting the criteria.

What fast track provides

A sponsor may request fast track with its Investigational New Drug (IND) application or later, ideally no later than the pre-NDA or pre-BLA meeting. Benefits include:

• More frequent meetings with the FDA about the development plan and the data needed for approval.
• More frequent written communication about topics such as trial design and the use of biomarkers.
• Rolling review: the sponsor can submit completed sections of the marketing application before the full application is ready.
• Eligibility for accelerated approval and priority review if the relevant criteria are met.

Why fast track matters

Fast track is granted far more often than breakthrough therapy designation, so it is a weaker signal. It still tells analysts the FDA agrees a product targets a serious condition with an unmet need, and rolling review can shorten the time from final data to approval.

In pipeline tracking, fast track is most useful combined with other data: development phase, indication, and whether the product later gains breakthrough therapy designation, priority review or accelerated approval. A designation alone does not predict approval.

Fast track vs breakthrough therapy designation

Both programs require a serious condition. Fast track needs only the potential to address an unmet need, which nonclinical data can show, while breakthrough therapy needs preliminary clinical evidence of substantial improvement over available therapy. Breakthrough therapy includes all fast track features and adds intensive FDA guidance and senior management involvement.