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FDA Guidance for Industry: M2 eCTD Specification Questions and Answers and Change Requests


Center for Biologics Evaluation and Research (CBER) Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448

Document Type:
Guidance for Industry
This document provides guidance to applicants on how to use the electronic Common Technical Document (eCTD) specification. The guidance also answers questions that have been raised about the eCTD specifications and provides a change request table that tracks the status of all change requests that have been received by ICH since the eCTD specification was issued. The information provided here reflects the consensus of the ICH parties. The questions and answers (Q&As) and the change request table have been developed as a stand alone document that is available with this guidance. The document will be updated when the eCTD specification undergoes change control or new questions are submitted to the ICH.

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