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A: Preclinical studies have explored concentrations from approximately 1 nM to 10 M in vitro, with in vivo models typically using formulations calibrated to deliver peptide within a physiologically relevant range at the wound site

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The same letter makes clear the peptides do not automatically move into Category 1 the bucket where the FDA has said it generally would not take action against compounders and that the Pharmacy Compounding Advisory Committee (PCAC) will review them at the July 2324, 2026 meeting, with February 2027 as the alternate date