RegulatoryGlossary Term
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.
Fast Track Designation represents one of several expedited programs created by Congress to accelerate the availability of treatments for serious conditions. Established by the FDA Modernization Act of 1997, the program recognizes that for certain diseases, the standard drug development timeline may impose unacceptable delays in patient access to potentially beneficial treatments. Fast Track designation provides a framework for enhanced collaboration between sponsors and FDA throughout development, potentially reducing development time without compromising review standards.
Eligibility for Fast Track Designation requires demonstration that the drug is intended to treat a serious or life-threatening condition and has the potential to address an unmet medical need. A serious condition is one with substantial impact on day-to-day functioning or whose consequences include mortality or serious morbidity. Unmet medical need exists when no therapy is available or when the drug may provide advantages over existing treatments. The determination considers the condition's severity, the available treatment options, and the drug's potential to offer meaningful improvement.
The primary benefits of Fast Track Designation include more frequent meetings and communications with FDA, written feedback on development plans, and eligibility for Rolling Review, which allows submission and review of completed sections of the marketing application before the entire submission is complete. This rolling approach can reduce overall review time by enabling FDA reviewers to begin evaluating portions of the application as they are submitted. Fast Track products may also qualify for Accelerated Approval and Priority Review if they meet additional criteria, potentially combining multiple expedited pathways.
Development program
"The antiviral drug received Fast Track Designation for treatment of drug-resistant HIV, enabling quarterly meetings with FDA reviewers to discuss development progress and address scientific questions throughout the Phase II and III programs."
Rolling Review
"Taking advantage of Rolling Review under Fast Track, the sponsor submitted the clinical section of the NDA while completing manufacturing process validation, enabling FDA review to begin months before the complete application was assembled."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA approval that allows an investigational medical device to be used in a clinical study to collect safety and effectiveness data required to support a premarket approval application or 510(k) submission.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.
Fast Track Designation represents one of several expedited programs created by Congress to accelerate the availability of treatments for serious conditions. Established by the FDA Modernization Act of 1997, the program recognizes that for certain diseases, the standard drug development timeline may impose unacceptable delays in patient access to potentially beneficial treatments. Fast Track designation provides a framework for enhanced collaboration between sponsors and FDA throughout development, potentially reducing development time without compromising review standards.
Eligibility for Fast Track Designation requires demonstration that the drug is intended to treat a serious or life-threatening condition and has the potential to address an unmet medical need. A serious condition is one with substantial impact on day-to-day functioning or whose consequences include mortality or serious morbidity. Unmet medical need exists when no therapy is available or when the drug may provide advantages over existing treatments. The determination considers the condition's severity, the available treatment options, and the drug's potential to offer meaningful improvement.
The primary benefits of Fast Track Designation include more frequent meetings and communications with FDA, written feedback on development plans, and eligibility for Rolling Review, which allows submission and review of completed sections of the marketing application before the entire submission is complete. This rolling approach can reduce overall review time by enabling FDA reviewers to begin evaluating portions of the application as they are submitted. Fast Track products may also qualify for Accelerated Approval and Priority Review if they meet additional criteria, potentially combining multiple expedited pathways.
Development program
"The antiviral drug received Fast Track Designation for treatment of drug-resistant HIV, enabling quarterly meetings with FDA reviewers to discuss development progress and address scientific questions throughout the Phase II and III programs."
Rolling Review
"Taking advantage of Rolling Review under Fast Track, the sponsor submitted the clinical section of the NDA while completing manufacturing process validation, enabling FDA review to begin months before the complete application was assembled."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA approval that allows an investigational medical device to be used in a clinical study to collect safety and effectiveness data required to support a premarket approval application or 510(k) submission.