Guidances and Other Resources

• All CDER Guidances on Electronic Submissions Select "Electronic Submissions" under Topic

• Electronic Common Technical Document (eCTD) 

• FDA Electronic Submissions Gateway (ESG)

• FDA Adverse Events Reporting System (FAERS) Electronic Submissions (Submitting ICSRs and Periodic Safety Reports)

• Structured Product Labeling (SPL)

• Providing Digital Electrocardiogram (ECG) Data

• FDA Forms

• Electronic Submissions Public Docket

• Electronic Common Technical Document (eCTD) Course

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Docket

• The Agency established the Electronic Submissions Public Docket number 92-0251 to provide a permanent location for a list of the Agency units that are prepared to receive electronic submissions, as well as a list of the specific types of regulatory records that can be accepted in electronic format (62 FR 13467, March 20, 1997).

Portable Document File (PDF) Format

• PDF is an open format developed by Adobe Systems. Additional information is available at http://www.adobe.com.

SAS Transport File Format

• We are able to archive data sets in SAS XPORT transport format, also called version 5 SAS transport format.  This is an open, published file format developed by SAS Institute. For additional information, see the SAS Institute's Standards for Electronic Submissions and SAS XPORT transport format web site.

Technical Assistance

• For more general information regarding the preparation of submissions in electronic format, please contact the Electronic Submissions Coordinator at esub@fda.hhs.gov.

Other ERSR Links

• CDER Electronic Records; Electronic Signature Regulations. This page provides links to pertinent Code of Federal Regulations and Federal Register documents.
   
• ERSR Agency Charter. Federal Register - Electronic Records; Electronic Signatures, Final Rule, March 20, 1997.