Research Articles

Two peptide molecular models compared with an analytical spectrum and regulatory checklist

FDA Generic Peptide Guidance 2026: What Changed?

FDA’s 2026 Generic Peptide Guidance: What Changed? Short answer: FDA’s generic peptide guidance update revised 17 product-specific guidances in July 2026. The drafts clarify recommendations for manufacturing approach, immune-response testing, impurity thresholds, higher-order structure, and biological activity. They do not approve a new generic product by themselves. The update matters because peptide drugs can be

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Peptide molecular model beside a review checklist and balance scale representing FDA advisory review

FDA Peptide Compounding Vote: What It Actually Means

FDA Peptide Compounding Vote: What It Actually Means Short answer: The FDA peptide compounding vote in July 2026 did not make BPC-157, KPV, TB-500, MOTS-C, Semax, or Epitalon FDA-approved drugs. An FDA advisory committee recommended that those six peptide-related substances be considered for the Section 503A Bulks List. The recommendations are nonbinding, and FDA must

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