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International Pharmaceutical Regulatory Monitor
September 2012 | Vol. 40 No. 9
Format Tweaks Needed Between FDA, EMA eCTD Submissions
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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