With IND or after and, ideally, no later than the pre-BLA or pre-NDA meeting

With the IND or after and, ideally, no later than the end-of-phase 2 meeting

Drug development phase before pre-BLA or pre-NDA meeting

With original BLA, NDA, or efficacy supplement

With the IND or after and, ideally, no later than the end-of-phase 2 meeting

Within 60 calendar days after receipt of request

Within 60 calendar days after receipt of request

Not specified

Within 60 calendar days of receipt of original BLA, NDA, or efficacy supplement

Within 60 calendar days after receipt of request

Frequent Interactions with FDA

Eligibility for Accelerated Approval and Priority Review

Rolling Review

All fast track designation features

Intensive guidance on efficient drug development, beginning as early as Phase 1

Organizational commitment involving senior managers

Approval based on an effect on a surrogate endpoint or an intermediate clinical endpoint that is reasonably likely to predict a drug’s clinical benefit

Shorter clock for review of marketing application (6 months compared with the 10- month standard review)

All breakthrough therapy designation features, including early interactions to discuss any potential surrogate or intermediate endpoints

Statute addresses potential ways to support accelerated approval and satisfy post-approval requirements