What is the difference between Fast Track Designation and Breakthrough therapy Designation?

Fast Track Designation and Breakthrough Therapy Designation are both programs offered by the U.S. Food and Drug Administration (FDA) to expedite the development and review of new drugs for serious conditions with unmet medical needs. However, there are some key differences between the two designations:

1.Breakthrough Therapy designation needs preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s), The request of Fast Track Designation can be initiated even before the clinical.

2. Fast Track designation must be requested by the drug company, Breakthrough Therapy designation is requested by the drug company. If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request.

3.A drug that receives Breakthrough Therapy designation is eligible for All Fast Track designation features.