Part 3 FDA Expedite Programs Series: Fast Track Designation

To facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. 

An unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. 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 clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
  • Ability to address emerging or anticipated public health need

Potential Benefits

  • More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
  • More frequent written communication 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 Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Fast Track Designation Process

  • Request may be submitted when the IND is first submitted or any time prior to pre-BLA or pre-NDA meeting. Decisions are made within 60 days from submission
  • Particulars are found in Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics (2014)