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

 
• By Sue Sutter

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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The US FDA’s final guidance on accelerated approval drug labeling distinguishes between therapeutic settings where surrogate endpoints are widely recognized, such as oncology, and those where such endpoints may be less well understood.

For the Indications and Usage section of some drugs, such as anti-cancer agents, it may be enough merely to state...

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