Snapshot

The FDA Fast Track pathway has been developed by the US Food and Drug Administration of United States.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

FDA will review the fast track designation request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.