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10.4049/jimmunol.161.5.2524 J Immunol
The published preclinical melanogenesis literature for MT-II is well-developed and reproducible across frog (Rana pipiens), lizard (Anolis carolinensis), and mammalian skin bioassays, where the cyclic peptide was reported as approximately 90-100 more potent than native -MSH [2]
10.1016/j.isci.2024.109737 84 PontelL
And so FDA is going to need to use a different lens. Unlike FDA approval of a new drug, which requires years of clinical trials demonstrating safety and effectiveness, placement on the 503A Bulks List answers a different regulatory question
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