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Accelerated Approval: US FDA Labeling Guidance Calls Out Surrogate Endpoints Needing ‘Additional Context’

Executive Summary

For Indications and Usage section of some drugs, such as anti-cancer agents, it may be enough merely to state that accelerated approval was based on a specific surrogate; however, labeling for other types of drugs may need to reflect the clinical outcomes that are expected but not yet established, agency says.

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