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However, he added that since many of these experimental peptides dont have the same robust catalog of clinical trial data as FDA-approved medications, evaluating them for the 503A Bulks List may prove challenging for the committee and the agency
doi:10.1111/j.1464-410X.2012.11577.x
Its impossible for me to not take the FDAs recommendations at heart with respect to safety and efficacy, said Kevin Zacharoff, a clinical assistant professor at Stony Brook University, who voted no to Emideltide
Grant, et al
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