Fast Track Designation
An FDA programme expediting development of drugs for serious conditions with unmet medical need. Fast track provides rolling review (submitting completed application sections as they are ready), more frequent FDA meetings, and eligibility for accelerated approval and priority review.
Technical Context
Fast Track eligibility: serious condition (conditions with substantial impact on daily functioning OR life-threatening if left untreated) AND unmet medical need (no therapy exists, or the new drug may offer advantage over existing therapy — improved efficacy, fewer side effects, activity in non-responders, or improved patient compliance). Fast Track features: more frequent FDA meetings (guidance on clinical development strategy, trial design, and use of biomarkers), rolling review (submit completed NDA/BLA sections as available rather than as complete package — can save 2-6 months), eligibility for accelerated approval (if evidence supports), and eligibility for priority review. Fast Track can be granted at any development stage (pre-IND through NDA filing). Multiple designations can be held simultaneously — a drug can have Fast Track, Breakthrough, Priority Review, and Accelerated Approval. Designation does not guarantee approval.