In 1997, the Food and Drug Administration (FDA) created the Fast Track Designation (FTD) program through the Food and Drug Administration Modernization Act. This designation facilitates faster drug development for serious diseases or conditions that are debilitating or life-threatening by enabling more direct communication with the FDA during the drug development process.
In this whitepaper, our experts cover the qualifications necessary for applying, the application process, and the key opportunities to take advantage of once designation is granted.
Written By:
Sreja Julakanti
Antony Kaprielian, Regulatory Operations Manager
