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regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including LEQEMBI

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For more information on the FDA and EtO, visit: Sterilization for Medical Devices (FDA 2023b) The NESHAP for Ethylene Oxide Emissions Standards for Commercial Sterilization and Fumigation Operations found in 40 Code of Federal Regulations (CFR) Part 63, Subpart O establishes emission standards for major and area sources that use at least 1 ton of EtO in sterilization or fumigation operations in any 12-month period (59 FR 6289 1994)

[3] In contrast, the diffusion of hydrophobic compounds across these barriers cannot be controlled, and organisms, therefore, cannot exclude lipid-soluble xenobiotics using membrane barriers