Electronic Common Technical Document; Data Standards; Specifications for the Electronic Common Technical Document Validation Criteria
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the date that FDA will begin rejecting submissions which fail Electronic Common Technical Document (eCTD) validations 1306 or 1323 that have been raised to high validation errors as described in the "Specifications for eCTD Validation Criteria."
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