CDER to Require eCTD Format for Electronic Submissions

International Pharmaceutical Regulatory Monitor
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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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