Electronic Regulatory Submissions and Review Helpful Links

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.

Portable Document File (PDF) Format

• PDF is an open format developed by Adobe Systems. Additional information is available on the Adobe web site.

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.