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Start Over You searched for: Genre Guideline Remove constraint Genre: Guideline Genre Technical Report Remove constraint Genre: Technical Report Publication Year 2000 to 2024 Remove constraint Publication Year: <span class="from" data-blrl-begin="2000">2000</span> to <span class="to" data-blrl-end="2024">2024</span>

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237. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators

238. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": guidance for industry and Food and Drug Administration staff