Vaccines, Blood & Biologics

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

Contact FDA

(800) 835-4709
(240) 402-8020
Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 05/18/2018
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