About Fast Track DesignationAccording to the FDA, in order to be granted Fast Track designation, a drug must (1) be intended for the treatment of a serious or life-threatening condition; and (2) demonstrate the potential to address unmet medical needs for the condition. A drug that receives Fast Track designation is eligible for some or all of the following:
- More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
- More frequent written correspondence from the FDA about such things as the design of the proposed clinical trials;
- Accelerated Approval , i.e., approval based on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit;
- Rolling Review, which means that a sponsor can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed; and
- Priority Review, with an FDA goal for completing review within eight months of submission.