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FDA ELECTRONIC SUBMISSIONS GATEWAY (ESG)



Links to Center-Specific Submission Preparation Guidelines


FDA Center Link
Center for Biologics Evaluation and Research (CBER) http://www.fda.gov/cber/esub/esub.htm
Center for Drug Evaluation and Research (CDER) http://www.fda.gov/cder/regulatory/ersr/default.htm
Center for Devices and Radiological Health (CDRH) http://www.fda.gov/cdrh/cesub
Adverse Event Reporting System (AERS) http://www.fda.gov/cder/aerssub/default.htm
Center for Veterinary Medicine (CVM) http://www.fda.gov/cvm/esubstoc.html
Office of the Commissioner (OC) http://www.fda.gov/oc/datacouncil/spl.html

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FDA Industry Systems Website Staff
May 1, 2008