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Accelerated Approval Pathways

Meaning

Accelerated Approval Pathways are a regulatory mechanism designed to expedite the market availability of medications intended to treat serious conditions that address an unmet medical need. This framework allows the U.S. Food and Drug Administration (FDA) to grant approval based on a surrogate endpoint rather than waiting for a direct measure of long-term clinical benefit. A surrogate endpoint is a laboratory measure or radiographic sign reasonably likely to predict a true therapeutic effect. This process prioritizes timely patient access to promising new therapies, especially in areas like oncology or rare endocrine diseases.