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The published briefing memos for prior PCAC peptide reviews have read as conservative on clinical-need findings: if there is a plausible FDA-approved alternative for the named indication mesalamine for ulcerative colitis, for instance the agency tends to find that the bulks-list path is unnecessary, regardless of whether the alternative is what compounding patients actually want
But peptides are also a buzzy focus in the skin care world
FDAs injectable-route concern highlights limited human safety data, aggregation risk, and peptide-related impurity concerns [8]
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