Breakthrough vs. Fast Track
According to the FDA, breakthrough therapy and fast track designation programs are both intended to expedite the development and review of drugs for serious or life-threatening conditions, but there are differences in what needs to be demonstrated to qualify for the programs.
A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates the drug may demonstrate substantial improvement on a clinically significant end point(s) over available therapies.
In contrast, a fast-track designation is for a drug that treats a serious or life-threatening condition, and nonclinical or clinical data demonstrate the potential to address unmet medical needs for the serious condition.
