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  1. Electronic Regulatory Submission and Review

Electronic Regulatory Submissions and Review Helpful Links

Guidances and Other Resources


Docket

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

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