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  1. Drug and Biologic Approval and IND Activity Reports

Fast Track Designation Requests

Fast Track Designation Requests

The Fast Track program facilitates the expedited development and review of new drugs or biologics that are intended to:  1) treat serious or life-threatening conditions and 2) demonstrate the potential to address unmet medical needs.  Sponsors typically request Fast Track Designation during the IND phase of drug development.
 
Title VIII of FDASIA (implemented July 9, 2012), Generating Antibiotic Incentives Now (GAIN), provides incentives for the development of antibacterial and antifungal drugs for human use intended to treat serious and life-threatening infections.  Under GAIN, a drug may be designated as a qualified infectious disease product (QIDP) if it meets the criteria outlined in the statute.  A drug that receives QIDP designation is eligible under the statute for fast track designation (upon request) and priority review.
 
This report provides information on traditional Fast Track Designation Requests, as well as requests received after July 9, 2012, that are associated with GAIN products.  This report will be updated during the first quarter of every fiscal year.

 


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