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Further, in making any budget neutrality adjustment under section 1833(t) of the Act, section 16002(b) of the 21st Century Cures Act provides that the Secretary shall not take into account the reduced expenditures that result from application of section 1833(t)(18)(C) of the Act

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This substitution may potentially increase the resistance of the peptide to enzymatic degradation and improve its stability

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As of June 2026, the FDA's December 2024 Pharmacy Compounding Advisory Committee evaluation concluded that the criteria weighed against placing AOD-9604 (free base) or AOD-9604 acetate on the 503A Bulks List, and AOD-9604 is currently listed as Nominated but Withdrawn from FDA Category 2