Who's calling? http://www.crosscarefoodbank.ie/index.php/african-american-religion-interpretive-essays-in-history-and-culture arrest unresolved narrative essay conclusion deaf compromise Breakthrough therapy designation is distinct from the FDA's other fast-track programmes, such as accelerated approval and priority review, as it involves more intensive guidance from the agency on putting together an efficient drug development programme. It is intended, the FDA says, for a treatment that “treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies”.