I want Module 1 Common Technical Document (CTD) format of choice for NDAs submitted to the FDA. What documents should have submitted by NDA to FDA? Is there any official link to submit all CTD, give me the procedure to submitting? Give me guidelines for Common Technical Document?

Don’t worry I will get the Food and Drug Administration, NDA eCTD Technical Conformance Guide so that it would be easy for you to check module 1.

Here are the content which come under file

Introduction

BACKGROUND

PURPOSE

DOCUMENT REVISION AND CONTROL

RELATIONSHIP TO OTHER DOCUMENTS

General Considerations

ECTD PUBLISHING

ECTD SAMPLES

TRANSITIONING TO ECTD FORMAT AND RESUBMISSION OF NON-ECTD DOCUMENTS

Transitioning from Paper to eCTD using us-regional v2.01 2.3.2 Transitioning from
Paper to eCTD using us-regional v3.3

Transitioning from us-regional v2.01 to us-regional v3.3
Resubmission of non-eCTD documents

ECTD LEAF TITLES

ECTD LIFE CYCLE

PRESUBMISSIONS

ROLLING SUBMISSIONS

STUDY TAGGING FILES




For full information please check the file

Address:-
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Phone:-
1-888-INFO-FDA (1-888-463-6332)

Attached Files

NDA eCTD Technical Conformance Guide.pdf (302.5 KB, 230 views)