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Presented for research literature review only Lenney W et al

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Inclusion is only one condition under section 503A

During the open public hearing before the vote, FDA's Russell Wesdyk raised a pointed question that encapsulated the agency staff position: "What is BPC-157?" noting that the FDA had encountered multiple substances all marketed as "BPC-157" with different active molecules, and that inconsistent naming conventions alone were sufficient to prevent adequate safety and effectiveness assessment

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