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International Pharmaceutical Regulatory Monitor
April 2007 | Vol. 35 No. 4
CDER to Require eCTD Format for Electronic Submissions
Drug manufacturers choosing to submit applications to the U.S. Center for Drug Evaluation and Research (CDER) electronically — as opposed to on paper — will have to use a particular electronic format called the electronic common technical document (eCTD) starting Jan. 1, 2008, a U.S. Food and Drug Administration (FDA) official said.
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