Fast Track — What It Means in Clinical Trials
Plain English Definition
Fast track is an FDA designation that speeds up the review of drugs intended to treat serious conditions where there is an unmet medical need. Fast track drugs may qualify for more frequent meetings with the FDA, rolling review (submitting data as it becomes available), and priority review. It is a less intensive designation than breakthrough therapy.
Why It Matters
Fast track designation means the FDA recognizes that this drug addresses an important gap in treatment. It may reach approval more quickly, which could benefit you sooner.
Example
A listing might mention: "This drug has received Fast Track designation from the FDA for the treatment of ALS."
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