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FDA Category 2 status AOD-9604 was previously nominated for inclusion under FDA's Category 2 list (substances proposed for compounding under research/evaluation)

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10.1016/S1474-4422(17)30158-8 Lancet Neurol

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Compliance and Safety Considerations: What Users Should Know Legal Status and Regulatory Classification: Regulatory status around peptides continues to evolve, and agencies have issued advisories and taken enforcement actions against peptide-related products depending on claims, intent for human use, and other factors