Regulatory Roundup—July 2026
• In July 2026, the FDA advanced regulatory modernization by approving 17 generic peptide products, including high-profile drugs semaglutide and tirzepatide. • The agency issued new guidance tightening expectations for structural characterization, impurity thresholds, and immunogenicity testing for these peptides. • Additional regulatory progress was made with the publication of new guidance documents regarding the development of psychedelic drugs.
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