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.
أمثلة
- Gilead's remdesivir for COVID-19
- Ibrance (palbociclib) for breast cancer
- Trikafta (elexacaftor/tezacaftor/ivacaftor) for cystic fibrosis
هل تعلم؟
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 …