Accelerated Approval
/əˈksɛləˌreɪtɪd əˈpruːvəl/
Definitions
- (n.) A regulatory pathway allowing earlier approval of drugs that address serious conditions based on surrogate endpoints.
The FDA granted accelerated approval to the new cancer drug to reach patients faster.
See also
Commentary
Accelerated approval expedites availability of therapies but often requires post-marketing studies to verify clinical benefit.
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