Linda Burek, Director
Cathie Schumaker, Deputy Director

About OIM

The Office of Information Management has been established to provide a more effective and efficient approach to information management within the Center.  The Office provides a focal point for:   

• Establishing standards for regulatory and health data standards; standards for paper and electronic submissions 
• Training for use of review tools 
• Coordination of systems development projects with the Office of Information Technology 
• Reports and analysis of drug review information 
• Oversight of CDER databases

OIM Organization and Responsibilities

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Electronic Submissions Information

• Electronic Regulatory Submissions and Review web page
  • Docket
  • Portable Document File Format (PDF)
  • SAS Transport File Format
  • Technical Assistance
  • Recent Presentations  
  • Questions and Answers
  • 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.

  • Please send questions regarding electrononic submissions to: esub@cder.fda.gov. 

Submission of Electronic Documents

Send all electronic submissions (except ANDAs) to:

5901-B Ammendale Road
Beltsville, MD 20705

Send ANDA submissions to:

7500 Standish Place, E-150
Rockville, MD 20855

Contact Us

Please contact us if you have any questions. 

Phone: 301-594-5411
Fax: 301-827-1540
Please send questions regarding electronic submissions to: esub@cder.fda.gov. 

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