Fda ctd table of contents

Pages

• eCTD webpage
  
• Submit Using eCTD
• Requesting a Pre-Assigned Application number
• Electronic Submission Gateway (ESG)
• Study Data for Submissions to CDER and CBER
• Drug Master Files

Guidance Documents ������������������

• Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications
• Guidance for Industry, Providing Regulatory Submissions in Electronic Format�Standardized Study Data
• Final Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location within the Common Technical Document
• Clarification for question #10 of "ICH M4: The CTD -- Efficacy Q&As" on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format

eCTD Specifications
The following specifications are located in the eCTD Submissions Standards Catalog on www.fda.gov

• eCTD Technical Conformance Guide
• FDA eCTD Table of Contents Headings and Hierarchy �
• eCTD Backbone Files Specification for Module 1
• eCTD Backbone File Specification for Modules 2 through 5 3.2.2 �
• The eCTD Backbone File Specification for Study Tagging Files 2.6.1
• Specifications for eCTD Validation Criteria
• Portable Document Format Specifications �
• Transmission Specifications
• �. and more

Study Data Resources
The following are located on the Study Data Standards Resources page:

• FDA Data Standards Catalog
• Study Data Technical Conformance Guide
• CDER/CBER Study Data Standardization Plan Recommendations
• Technical Rejection Criteria for Study Data

General Information

• Electronic Submissions Presentations
• CDERLearn
• CDER SBIA
• CDER SBIA Learn