Accelerated approval

FDA pathway allowing approval based on a surrogate endpoint, requiring confirmatory post-approval trials.

Definition

Accelerated approval is an FDA pathway under 21 CFR 314 Subpart H that permits approval based on a surrogate endpoint reasonably likely to predict clinical benefit. The sponsor must commit to a confirmatory post-marketing trial; failure to confirm benefit can trigger withdrawal of approval.

See also

• Breakthrough Therapy — FDA designation that fast-tracks review of drugs with substantial improvement on clinically significant endpoints.
• Priority review — FDA designation that shortens NDA/BLA review to 6 months for drugs offering significant improvement.
• Surrogate endpoint — A measurable biomarker (e.g. tumour shrinkage, LDL) used as a proxy for a clinical benefit.

Other regulatory terms

• NDA
• BLA
• PDUFA date
• Priority review
• Breakthrough Therapy
• Orphan drug