Table 1.

 Food and Drug Administration expedited development and review programs

Program name	Year instituted	Characteristics of qualifying products	Does it formally change evidentiary standard?	Phase during which it exerts most direct effect
Orphan drug	1983	Treats disease occurring in <200 000 people per year in United States	No	Drug development
Fast track	1988	Treats life threatening or severely debilitating diseases	Yes; can approve after single phase 2 study	Drug development and FDA review
Priority review	1992	Seems to offer therapeutic advance over available therapy	No	FDA review
Accelerated approval	1992	Treats serious or life threatening illnesses	Yes; can approve on basis of surrogate endpoint reasonably likely to predict patient benefit	Drug development and FDA review
Breakthrough therapy	2012	Treats serious disease for which preliminary clinical evidence suggests substantial improvement over existing therapies on one or more clinically important endpoints	No	Drug development and FDA review