Regulatory Submissions in Electronic Format

There are extensive requirements in the Code of Federal Regulations (CFR) regarding the information that needs to be submitted in order to seek approval to begin clinical testing of a biologic product and to market a biologic product. FDA has started the transition to a more automated electronic review process for these submissions.

Information pertaining to the electronic submission of regulatory documents to CBER

• Electronic IND Demo
• Food and Drug Administration Electronic Submissions Gateway (Federal Register Notice) - 8/9/2006
• FDA Announces the Use of New Electronic Drug Labels to Help Better Inform the Public and Improve Patient Safety - 11/2/2005
• Guidances and Rules Related to Regulatory Submissions in Electronic Format
• Nonclinical and Clinical Datasets; Notice of Pilot Project - 12/30/2004
• SOPP 8110: Submission of Regulatory Documents to CBER

CBER Information

Useful Government Sites