Definition · Plain-language
Accelerated approval
Accelerated Approval is an FDA pathway that allows earlier approval of drugs for serious conditions based on a surrogate endpoint, with confirmatory trials required after approval.
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How Accelerated Approval works
Accelerated Approval allows the FDA to approve a drug for a serious or life-threatening condition that provides a meaningful advantage over available therapies based on a surrogate endpoint — a laboratory measure, radiographic image or other marker — that is reasonably likely to predict clinical benefit, rather than waiting for direct evidence of that benefit (such as improved survival). It can also rely on an intermediate clinical endpoint. This can bring promising treatments to patients sooner, because the predictive marker may be measurable well before the ultimate clinical outcome.
The confirmatory-trial requirement
Because approval rests on a surrogate that is reasonably likely to — but has not yet been shown to — predict benefit, Accelerated Approval is conditional. Sponsors are generally required to conduct post-approval confirmatory trials to verify and describe the anticipated clinical benefit. If the confirmatory trials confirm benefit, the drug can convert to traditional approval; if they fail to do so, the FDA has procedures to withdraw the approval. Legislation has strengthened the FDA’s authority to require and enforce these confirmatory studies.
Where it fits and what it is not
Accelerated Approval is one of the FDA’s four expedited programmes for serious conditions, alongside Fast Track, Breakthrough Therapy and Priority Review, and it is the only one of the four that is itself an approval pathway rather than a development or review designation. It does not lower the standard of safety; instead it changes the type of efficacy evidence on which initial approval can rest, while building in a requirement to confirm the benefit after the fact.
Key facts
At a glance
- Definition: Approval on a surrogate endpoint reasonably likely to predict benefit.
- Applies to: Serious or life-threatening conditions with unmet need.
- Basis: Surrogate or intermediate clinical endpoint, not final outcome.
- Condition: Confirmatory trials required to verify clinical benefit.
- If unconfirmed: The FDA can withdraw the approval.
- Type: The only one of the four expedited programmes that is an approval pathway.
Common misconceptions
What people often get wrong
Often heard: Accelerated Approval means the drug’s clinical benefit is already proven.
Actually: It rests on a surrogate endpoint reasonably likely to predict benefit, not yet on confirmed clinical benefit. Confirmatory trials are required afterwards to verify that the benefit is real.
Often heard: Accelerated Approval lowers the FDA’s safety standard.
Actually: It changes the kind of efficacy evidence supporting initial approval — allowing a surrogate endpoint — but it does not relax the requirement that the drug be acceptably safe for its intended use.
Often heard: An accelerated approval can never be reversed.
Actually: If required confirmatory trials fail to verify clinical benefit, or are not conducted, the FDA has procedures to withdraw an accelerated approval. The pathway is conditional by design.
