FDA: Federal Register Docket published - Draft Documents to Support Submission of an Electronic Common Technical Document (The eCTD Backbone Files Specification for Module 1 version 2.0) - Submit either electronic or written comments

FDA: Federal Register Docket published - Draft Documents to Support Submission of an Electronic Common Technical Document (The eCTD Backbone Files Specification for Module 1 version 2.0) - Submit either electronic or written comments The Food and Drug Administration (FDA) is announcing the availability of the following draft versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications entitled "The eCTD Backbone Files Specification for Module 1, version 2.0" (which includes the U.S. regional document type definition, version 3.0) and
"Comprehensive Table of Contents Headings and Hierarchy, version 2.0." Supporting technical files are also being made available on the Agency Web site. These draft documents represent FDA's major updates to Module 1 of the eCTD, which contains regional information.

DATES: Submit either electronic or written comments on the draft documents by [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER].

ADDRESSES: Submit written requests for single copies of the documents to the

Division of Drug Information,
Center for Drug Evaluation and Research (CDER).
Food and Drug Administration (FDA),
10903 New Hampshire Ave.,
Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002.

To find more information please click here: FDA: Federal Register Docket published - Draft Documents to Support Submission of an Electronic Common Technical Document (The eCTD Backbone Files Specification for Module 1 version 2.0) - Submit either electronic or written comments