Regulatory Submissions in Electronic Format
Guidances and Rules
Technical specifications associated with this guidance will be provided as stand alone documents. They will be updated periodically independent of the guidance. To ensure that you have the most recent versions of the stand alone documents, check the appropriate center's guidance Web page. For CBER, this Web page is http://www.fda.gov/cber/esub/icsr.htm. For CDER, this Web page is http://www.fda.gov/cder/regulatory/ersr/#Postmarketing.
- eCTD Backbone Files Specification for Module 1 (updated 12/13/2006) (PDF 102 KB)
- eCTD Backbone File Specification for Modules 2 through 5 (PDF 204 KB)
- FDA eCTD Table of Contents Headings and Hierarchy (updated 7/7/2005) (PDF 74 KB)
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations - 1/28/1999
REVISED Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA) / Establishment License Application (ELA) and New Drug Application (NDA)] - 11/12/1999, REVISED 11/22/1999