What does “fast track” designation by the FDA signify?

The "fast track" designation by the FDA signifies an expedited review process for drugs that are intended to treat serious conditions and fill an unmet medical need. This designation aims to facilitate the development and expedite the review of these therapies, with the goal of making them available to patients as quickly as possible. When a product receives this designation, it can benefit from features such as more frequent interactions with the FDA and the possibility of rolling reviews, where portions of the application are reviewed as they are submitted, rather than waiting for a complete submission.

This designation is especially important for conditions where there are few or no existing treatment options, as it reflects the FDA's commitment to bringing important new therapies to market swiftly and efficiently. Other options do not accurately describe the nature or intent of the fast track designation. For example, it does not involve a longer review period or automatic approval, nor does it signify a deferral for further testing.