Module 1 Education

FDA Module 1 v2.3 Specifications

As of June 15, 2015, the US FDA is accepting eCTD submissions using the new Module 1 specifications (us regional DTD v3.3).

Using the new M1 is optional unless you are submitting promotional labeling and advertising materials to CDER OPDP or taking advantage of grouped submissions functionality.

After transitioning an application to the new M1, that application must continue to use the new M1.

Recent FDA Presentations Related to Module 1 Changes

FDA Update: Submission of Promotional Materials, CDR Roberta Szydlo, RPh, MBA, RAC, Senior Regulatory Review Officer, Office of Prescription Drug Promotion, CDER – DIA eRI, May 11, 2015

FDA’s Module 1 Update, Jared Lantzy, PMP, Division of Data Management Services & Solutions, Office of Business Informatics, CDER – DIA eRI, May 12, 2015

FDA Module 1 Educational Resources – eCTD Summit Blog

15 Takeaways – FDA’s New Module 1 (Published on May 22, 2015)

Module 1 Metadata Evolves to Meet End Goal of Efficient Submission Review (Published on June 2, 2015)

Modernizing to Keep Pace with Submission Volume is Ad Promo Priority (Published on June 12, 2015)

Industry Q&A – Ad Promo Submissions (Published on June 18, 2015)

Cc: Grouped Submissions (Published on June 19, 2015)

Grouped Submissions Q&A – Part 1 (Published on June 26, 2015)

A Look at FDA Submission Metrics for Module 1 (Published March 18, 2016)

FDA Module 1 Webinars

Using the New FDA Metadata (Recorded June 9, 2015 – Running Time 39:04)

Advertising & Promotional Submissions (Recorded June 16, 2015 – Running Time 47:37)

Grouped Submissions (Recorded June 23, 2016 – Running Time 56:05)

M1 v2.3 and Supportive Files

The eCTD Backbone Files Specification for Module 1 Version 2.3

Comprehensive Table of Contents Headings and Hierarchy Version 2.3

Addendum to the eCTD Backbone Files Specification for Module 1 Version 2.3

Addendum 2 to the eCTD Backbone Files Specification for Module 1 Version 2.3

Example Submissions using the eCTD Backbone Files Specification for Module 1 Version 1.4

Specifications for eCTD Validation Criteria Version 3.1 (PDF)

Specifications for eCTD Validation Criteria Version 3.1 (XLS)

US Regional DTD v3.3

US Regional Stylesheet