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Microscopically manifest as a proliferation of atypical melanocytes at the basal level of the epidermis and within the hair follicles, nesting of atypical melanocytes, and effacement of rete ridges

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FDA approval requires formal clinical trials, safety and efficacy review, labeling approval, and manufacturing validation under a New Drug Application (NDA) or Biologics License Application (BLA)

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Once reconstituted, keep it refrigerated at 28C and use within the documented research window