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):  [email protected]
3. Electronic media (USB drive, DVD/CD) with no paper components
4. Paper submissions

Key Resources

• Frequently Asked Questions (FAQs): Electronic Submissions Program for CBER-Regulated Products
• Electronic Common Technical Document (eCTD)
• eCopy Program for Medical Device Submissions
• Study Data for Submission to CDER and CBER
• Structured Product Labeling Resources (SPL)
• Electronic Submission of Postmarket Safety Reports
• Electronic Submissions Gateway (ESG)
• Drug Master Files
• Labeling for CBER-Regulated Products
• Tissue Establishment Registration
• Blood Establishment Registration and Product Listing

Additional Resources

• CBER Application Submissions Guidance
• SOPP 8117: Issuing Tracking Numbers in Advance of Electronic Submissions in eCTD Format
• SOPP 8422: Processing Trans-BLA Submissions
• Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers
• Electronic Submission of Lot Distribution Reports; Guidance for Industry
• Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format
• IND Safety Reporting
• Identification of Medicinal Products (IDMP)
• Drug Development Tool (DDT) Qualification Programs