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Accelerated Approval: US FDA Explains ‘Reasonably Likely’ Determination Criteria

 
• By Sue Sutter

New draft guidance discusses the data necessary for deciding whether an effect on a surrogate or intermediate clinical endpoint is reasonably like to predict clinical benefit and can support accelerated approval.

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A new draft guidance clarifies how the FDA decides when an effect on a surrogate endpoint is reasonably likely to predict clinical benefit. (Shutterstock)

The US Food and Drug Administration’s new draft guidance on accelerated approval explains the criteria for determining whether a surrogate marker or intermediate clinical endpoint are reasonably likely to predict clinical benefit, offering some clarification of the decision-making process for sponsors and advocates.

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