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Supplemental PMTAs must still contain the information required by section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act, but they may meet these requirements by cross-referencing content from the relevant previously authorized PMTA and by providing new information related to the product modifications

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There are also lymphocytes and histiocytes in the connective tissue surrounding deeper blood vessels near to the ulcer, described histologically as "perivascular cuffing"