FDA will review the request and attempt to make a decision within sixty days.
Serious condition: determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will affect such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.
If there are existing therapies, a fast track eligible drug must show some advantage over available treatment, such as: A drug that receives a fast track designation is eligible for some or all of the following:[3] An FDA decision not to grant fast track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research.
The drug sponsor can subsequently utilize the Agency's procedures for internal review or dispute resolution if necessary.
The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.