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Format Tweaks Needed Between FDA, EMA eCTD Submissions
September 10, 2012
Drugmakers submitting electronic common technical document (eCTD) marketing applications to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) can basically clone their submissions, but the format must be reworked to meet the needs of each agency, an eCTD expert advises.
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