Fast Track Designation is a process by the U.S. Food and Drug Administration (FDA) designed to expedite the review of drugs that treat serious conditions and fill an unmet medical need. This designation aims to bring important new drugs to patients more quickly by facilitating more frequent interactions with the FDA and allowing for a rolling review of the drug's application.

Fast Track Designation

U.S. Food and Drug Administration

Expedited review of drugs

Serious conditions refer to medical or health issues that pose significant risk to an individual's well-being, potentially leading to severe complications or death if not properly managed. These conditions often require immediate attention, specialized treatment, and ongoing management to mitigate risks and improve quality of life.

Serious Conditions

Unmet medical need refers to a condition or disease for which there exists no satisfactory method of diagnosis, prevention, or treatment, or where existing solutions are inadequate. Addressing these needs is crucial for advancing healthcare outcomes and driving innovation in medical research and development.

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