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The result is a net positive on structural protein density over time

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The 2023 NEEL gel IRB study reported an average 28% increase in skin collagen density at 3 months

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Specifically regarding product-related impurities or variants, the guidance states that manufacturers should justify for each new specified peptide-related impurity the ANDA applicant should provide justification for why such impurity does not affect the safety of the proposed generic synthetic peptide (including with respect to immunogenicity) and why it does not affect its effectiveness

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