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  1. Development & Approval Process (CBER)

Regulatory Submissions in Electronic Format for CBER-Regulated Products

To facilitate FDA’s transition to a fully automated electronic submission and review process, many of the FDA electronic submission standards are now mandatory. It’s important to understand these requirements in order to seek approval to begin clinical testing of a biologic product, to market a biologic product, and to provide post marketing information and updates.

Most submissions are sent electronically through FDA’s Electronic Submission Gateway. For submissions exempted from 745(A) binding guidance and not subject to CBER Applications Submissions Guidance please submit in the following manner (in order of preference):

  1. FDA Electronic Submission Gateway
  2. CBER submission email box (150MB max):  CBERDCC_eMailSub@fda.hhs.gov
  3. Electronic media (USB drive, DVD/CD) with no paper components
  4. Paper submissions

Although electronic or email submission is preferred, requestors may submit paper or electronic media (USB drive, CD, DVD) documents and other regulatory correspondence to the Document Control Center at CBER mailing address:

U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002

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