The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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

Internet:

https://www.gmp-compliance.org/files/guidemgr/6339fnl.pdf

Origin/Publisher:

Center for Biologics Evaluation and Research (CBER) Food and Drug Administration 1401 Rockville Pike, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073244.pdf Rockville, MD 20852-1448

Document Type:
Guidance for Industry
Content:
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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