HealthWACH: Fast Track


The Fast Track programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a Fast Track drug must show some advantage over available therapy, such as:

  • Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes.

  • Avoiding serious side effects of an available therapy.

  • Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome.

  • Decreasing a clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment.

A drug that receives Fast Track designation is eligible for some or all of the following:

  • More frequent meetings with FDA to discuss the drugâ??s development plan and ensure collection of appropriate data needed to support drug approval.

  • More frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers.

  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.

  • Rolling Review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.