Table 5. FDA Expedited Programs for Serious Conditions.

Items	Fast track designation	Breakthrough therapy designation	Accelerated approval pathway	Priority review designation
When to submit	With IND and no later than the pre-BLA or pre-NDA meeting	With IND and no later than the end-of-Phase 2 meeting	Discuss with FDA review division	With original BLA, NDA, or efficacy supplement
FDA response	Within 60 calendar days	Within 60 calendar days	Not specified	Within 60 calendar days
Reference	FDA Modernization Act of 1997 (FDAMA), amended by FDASIA	Section 506 (a) of the FD&C Act, as added by FDASIA	21 CFR part 314, subpart H; 21 CFR part 601, subpart E; Section 506(c) of the FD&C Act, as amended by FDASIA	Prescription Drug User Fee Act of 1992