About FDA
Office of Information Management (OIM)
- About OIM
- Organization and Responsibilities
- Electronic Submissions Info
- Submission of Electronic Documents and Original Applications
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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
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.
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ERSR Agency Charter. Federal Register - Electronic Records; Electronic Signatures, Final Rule, March 20, 1997.
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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.