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Buse JB, Bode BW, Mertens A, et al

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and decision to submit the manuscript for publication

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Few of these companies pay GDUFA DMF fees, even though many file DMFsan entirely unnecessary step if they are not working with generic drug applicants, but a useful one because they can market the fact that they have a DMF on file with FDA, playing up on the likely lack of buyer awareness that FDA has not reviewed that file