Evidence-appraisal glossary
Accelerated approval
Accelerated approval is a regulatory pathway that lets a drug be marketed based on a surrogate endpoint judged reasonably likely to predict clinical benefit, before that benefit is directly confirmed. It trades earlier access for greater uncertainty, with confirmatory studies required afterward.
Also called: conditional approval, conditional marketing authorization.
This pathway is used for serious conditions with unmet need, letting patients receive a treatment sooner while trials continue to test real outcomes. The central caveat is that a surrogate can move without translating into longer or better lives, and some accelerated approvals are later withdrawn when confirmatory trials fail. An accelerated approval signals promise on a proxy measure, not proven benefit on the outcomes that matter to patients.
This is a plain-language methodology definition for reading research. It is general education, not medical advice.