Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. An investigational new drug intended to treat a serious condition, and for which non-clinical or clinical data demonstrate the potential to address an unmet medical need in patients with such condition, can receive Fast Track designation. [4]
In addition, such a product could be eligible for Priority Review if supported by clinical data at the time of marketing application submission. Fast Track designation must be requested by the drug company/sponsor – the request can be initiated at any time during the drug development process. The FDA will review the request and decide within 60 days based on whether the drug fills an unmet medical need in a serious condition. [6]