fast track designation
FDA designation intended to facilitate development and expedite reviews of drugs/instruments intended to treat a serious or life-threatening condition and address unmet medical needs for such a condition. The manufacturer, or sponsor, submits an application requesting a fast track designation from the FDA, which may (conditionally) or may not approve the application based on the criteria mentioned above. If a fast track designation is granted, the manufacturer may submit data to the FDA during the clinical trial process and thus speed up the regulatory review process leading to final approval. Source/detailed information: FDA Modernization Act of 1997, Section 112 - 07/09/98