Table. Characteristics of the FDA’s Expedited Programs for Drugs Treating Serious Diseasesa.
| Characteristics | Accelerated Approval Program | Priority Review Programb | Fast-Track Program | Breakthrough Therapy Program |
|---|---|---|---|---|
| Year issued or enacted | 1992c | 1992d | 1997e | 2012 |
| Approval based on effect on a surrogate measure or intermediate end point reasonably likely to predict clinical benefit | ✓ | |||
| Shorter FDA review time | ✓ | |||
| Rolling review of application | ✓ | ✓ | ||
| Actions to expedite development process | ✓ | ✓ | ||
| Organizational commitment and intensive guidance on efficient drug developmentf | ✓ |
Abbreviation: FDA, US Food and Drug Administration.
a
Drugs may qualify for more than 1 expedited program.
b
Priority review aims to provide FDA decision within 6 mo vs 10 mo for standard review.
c
The FDA’s subpart H (21 CFR §314.500-§314.560; drugs) and subpart E (21 CFR §601.40-§601.46; biologics) regulations were issued in 1992.
d
From 1975 through 1992, the FDA prioritized drug review using a 3-tiered system: type A, type B, and type C.
e
The FDA’s subpart E regulations (21 CFR §312.80-§312.88) were issued in 1988; Congress codified fast-track in 1997.
f
The 1988 subpart E regulations also provided for early consultation and the involvement of senior FDA officials.