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  1. Development & Approval Process (CBER)

Regulatory Submissions in Electronic Format for Biologic Products

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.

Key Resources

Information on Electronic Submission of Regulatory Documents to CBER

Guidances & Rules