Regulatory Submissions in Electronic Format
Guidances and Rules
Guidance for Industry: Indexing Structured Product Labeling (Revision 1) - 6/17/2008
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: Computerized Systems Used in Clinical Investigations - 5/10/2007
Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling - 4/20/2005
FEDERAL REGISTER Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format; Final Rule - 12/11/2003 - (PDF), (Text)
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations - 10/22/2003
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations - 1/28/1999
Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application - 9/3/2003