US FDA Guidance

FDA eCTD Guidance Documents

2016

Draft Guidance – Providing Regulatory Submissions in Electronic Format – Submission of Manufacturing Establishment Information (12/28/2016)

Technical Rejection Criteria for Study Data (10/3/2016)

Transmitting Electronic Submissions Using eCTD Specifications (03/04/2015)

2015

Electronic Common Technical Document Technical Conformance Guide (10/5/2015)

Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (5/5/2015)

Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs (4/22/2015)

2014

Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (December 17, 2014)

ANDA Submissions – Prior Approval Supplements Under GDUFA

ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA

ANDA Submissions – Content and Format of Abbreviated New Drug Applications

Providing Submissions in Electronic Format – Postmarketing Safety Reports

Expedited Programs for Serious Conditions – Drugs and Biologics

Information on the eCTD Module 1 Update and Implementation Plans

Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the Federal Food, Drug and Cosmetic Act

PDUFA V Information Technology Plan FY 2013 – FY 2017

GDUFA Information Technology Plan FY 2013 – FY 2017

2013

FDA Draft Guidance: ANDA Submissions – Refuse-to-Receive Standards

The eCTD Backbone Files Specification for Module 1, Version 2.2

The Comprehensive Table of Contents Headings and Hierarchy, Version 2.2

Specifications for eCTD Validation Criteria, Version 3.0

Example Submissions using eCTD Backbone Files Specification for Module 1, Version 1.2

CDER Data Standards Program Action Plan

Specifications for File Format Types Using eCTD Specifications