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Zdrowie i gospodarka · 8/30/2021

Electronic Common Technical Document; Data Standards; Specifications for Electronic Common Technical Document Validation Criteria

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing the date that FDA will begin rejecting submissions that fail either Electronic Common Technical Document (eCTD) validation 1551 or 1553, which are high severity validation errors as described in the Specifications for eCTD Validation Criteria. Validation errors 1551 and 1553 have been added to the Specifications for eCTD Validation Criteria.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →