Fast Track Designation

An FDA process designed to facilitate development and expedite review of drugs treating serious conditions that fill an unmet medical need. Allows rolling review of NDA/BLA sections as they are completed rather than waiting for the entire application. May be combined with Priority Review, Accelerated Approval, or Breakthrough Therapy designation.

Exemples

• Gilead's remdesivir for COVID-19
• Ibrance (palbociclib) for breast cancer
• Trikafta (elexacaftor/tezacaftor/ivacaftor) for cystic fibrosis