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π¨PCAC voted no on DSIP / emideltide and yes on Semax and Epitalon for recommendation to the 503A Bulks List. This is a meaningful regulatory signalβbut it is not an FDA approval
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For instance, in each of the warning letters to Xcel Research, Prime Vitality, Summit Research, and Swisschem, FDA observed that the companies marketed their products as for βresearch use only,β but also observed from the companiesβ websites and social media pages that the companies intended the products to be used by human patients
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