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FDAs July 2026 briefing document states that the agency did not intend to issue a final determination until it considered committee input and completed its reviews

10.1093/cvr/cvr071 91 KoppK

48 There is a circumscribed subjacent proliferation of mitotically active melanocytes (Figure 10) that extends to lie in direct apposition to either a smooth, papillomatous or verrucous epidermis