FDA Advisory Committee Recommends Six Peptides for Compounding: What the Evaluation Criteria Tell Us About the Road Ahead

Key Takeaways PCAC recommended inclusion of six peptides despite FDA staff opposition. On July 23 and 24, the PCAC voted by margins ranging from 7–4 to 8–6 to recommend the addition of BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax to the Section 503A Bulk Drug Substances List (503A Bulks List), while voting against Emideltide (also … Continued