What Should IRBs Consider in Reviewing Individual Expanded Access Submissions?

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What Should IRBs Consider in Reviewing Individual Expanded Access Submissions?

J.W. Schomisch

September 13, 2023 at 09:10 AM EST

The FDA released final guidance for immediate implementation that provides recommendations regarding the key factors and procedures institutional review boards (IRBs) should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to fulfill their obligations under 21 C.F.R. Part 56. The final guida... Read More

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What Should IRBs Consider in Reviewing Individual Expanded Access Submissions?

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