FDA Fast Track

What Is It

Fast Track (FT) is a process designed to facilitate the drug development process and expedite review for drugs that treat serious conditions and fill an unmet medical need.

Policy Events

Section 112 of the FDA Modernization Act of 1997 established the FT designation.1

Implications

FT emphasizes the importance of new drugs being delivered to the patients earlier and underscores the need for early communication with the FDA to improve the efficiency of drug development.

What You Need To Know

FT expedites the review of drugs that treat serious conditions and fill an unmet medical need. FDA determines whether a condition is serious based on if the drug will have an impact on factors such as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. Some examples of serious conditions are: AIDS, Alzheimer’s, heart failure, cancer, epilepsy, depression and diabetes. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that is potentially better than the ones available. A drug that treats or prevents a condition with no current therapy obviously fills an unmet need. However, if there are available therapies, a FT drug must: show superior effectiveness, reduce serious side effects of an available therapy, improve the diagnosis of a condition, decrease a clinically significant toxicity or address a public health need.2

FT designation must be requested by the pharmaceutical company at some point during the drug development process. FDA reviews the request and makes a decision within sixty days.1 A drug that receives FT designation can have more frequent meetings and written communication with the FDA to discuss the drug’s development (e.g. data collection, clinical trial design, biomarkers, etc.). The designation also makes the drug eligible for Rolling Review, where completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) are submitted for review prior to completion.2

Key Stats

Since its inception, FT has received 533 requests for the designation and granted 347 (65.1%).1

Fun Fact

With a FT designation the drug is also considered for Accelerated Approval and Priority Review.2

References

  1. Fast Track Designation Request Performance. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/fast-track-designation-request-performance.

  2. Fast Track. U.S. Food and Drug Administration. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.