Provides additional resources to review drugs that provide a significant improvement

Within 60 days, shorter clock for review of marketing application (6 vs. 10 months)

Does not affect clinical trial length or scientific / medical standard for approval or quality of evidence 

Facilitate development and expedite review for drugs that treat serious conditions and fill an unmet medical need

Enables manufacturer to have more frequent communication with FDA, must be requested by the manufacturer

Within 60 days

Within 60 days, includes rolling review and other actions to expedite review

FDA guidance to manufacturer on efficient drug development, preliminary evidence demonstrates that drug has substantial improvement for at least one clinically significant endpoint

Enables drugs for serious conditions that fill an unmet medical need to be approved based on a surrogate endpoint

Not specified

Manufacturers must complete confirmatory trials to verify clinical benefit, approval of the drug may be withdrawn if trials fail to verify the clinical benefit

Expedite development of drugs for serious or life-threatening conditions

Benefits

Timeline for FDA Response

Key Features

Accelerated Approval

Breakthrough Therapy

Fast Track

Priority Review