Fast Track

Fast Track is a designation by the United States Food and Drug Administration (FDA) that facilitates the development and expedites the review of drugs and vaccines intended to treat serious conditions and fill an unmet medical need.

Definition

The Fast Track process is designed to aid in the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

Criteria

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Benefits

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.

See also

• Orphan Drug
• Breakthrough Therapy
• Accelerated Approval
• Priority Review

External links

• FDA Fast Track

Fast Track Resources
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