Fda Breakthrough Therapy Designation-Trial Design And More - Commentary

Breakthrough Therapy designation is one tool that the US Food and Drug Administration (FDA) uses to expedite the development and review of drugs to treat a serious condition with an unmet need. The designation brings with it, among other benefits, increased opportunities for the sponsor to obtain FDA guidance on trial design and other aspects of the program. Although trial designs may be influenced by many factors, the true measure of success is bringing promising medications to patients earlier.