In the October 6, 2015, Federal Register, FDA announced the availability of an Electronic Common Technical Document ("eCTD") Technical Conformance Guide to supplement the guidance for industry titled "Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications." The eCTD provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submissions to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. Comments due November 20, 2015.
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