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Does the US FDA require approval before submitting eCTDs?

April 26, 2017Approval ectds fda require

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Does the US FDA require approval before submitting eCTDs?

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The FDA wants to assure that new organizations submitting eCTDs conform to the standards. To do this, the FDA requests that applicants notify the FDA of their plans to submit electronically and complete a sample submission process. Please see the FDAs website for additional information.