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Accelerated Approval Pathway

Meaning

The Accelerated Approval Pathway is a regulatory mechanism designed to expedite the availability of new medications intended to treat serious conditions that fill an unmet medical need. This process allows for drug approval based on a surrogate endpoint, which is a marker reasonably likely to predict clinical benefit, rather than waiting for definitive proof of long-term clinical outcome. This is particularly relevant in areas like oncology or rare endocrine disorders where traditional clinical trials may be lengthy or impractical. This conditional approval mandates continued post-marketing studies, known as Phase 4 confirmatory trials, to verify the anticipated clinical benefit.