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  1. Electronic Regulatory Submission and Review

Study Data for Submission to CDER

Information has been moved to: Study Data for Submission to CDER and CBER

CDER’s Study Data requirements are covered in the Data Standards Catalog and the Study Data Technical Conformance Guide available at: Study Data Standards Resources

Technical Assistance or questions regarding datasets should be forwarded to the CDER eDATA Team at cder-edata@fda.hhs.gov