Transcription of eCTD TECHNICAL CONFORMANCE GUIDE
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eCTD TECHNICAL CONFORMANCE GUIDE
ectd TECHNICAL CONFORMANCE GUIDE TECHNICAL Specifications Document This Document is incorporated by reference into the following Guidance Document(s): Guidance for Industry Providing Regulatory Submissions in Electronic Format Certain Human Pharmaceutical Product Applications and Related Submissions Using the ectd Specifications For questions regarding this TECHNICAL specifications document, contact CDER at or CBER at Department of Health and Human Services food and drug administration Center for drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) July 2020 ectd TECHNICAL CONFORMANCE GUIDE July 2020 REVISION HISTORY DATE VERSION SUMMARY OF REVISIONS October 2015 I n it ia l Versio n September 2016 Updated/Clarified following sections.
ectd technical conformance guide This technical specifications document represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.
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