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Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By Sue Sutter

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.

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The FDA's accelerated approval draft guidance describes an "uncertain standard" for identifying acceptable endpoints, PhRMA said. (Shutterstock)

The US Food and Drug Administration’s accelerated approval draft guidance has left stakeholders wanting more clarity on the process for determining a surrogate marker or intermediate clinical endpoint is “reasonably likely” to confirm clinical benefit.

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