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 In this section:

                Development & Approval Process (CBER)

Development & Approval Process (CBER)

                        2023 Biological Approvals
          2022 Biological Approvals
          Biological Approvals by Year
          Expanded Access to Experimental Biologics
          Vaccine Development – 101


                        Biologics License Applications (BLA) Process (CBER)
          Investigational New Drug Applications (INDs) for CBER-Regulated  Products
          Device Submissions for CBER-Regulated Products
          Labeling for CBER-Regulated Products
          Master Files for CBER-Regulated Products
          New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
          Formal Meetings for CBER-Regulated Products Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          Regulatory Submissions in Electronic Format for CBER-Regulated ProductsDevelopment & Approval Process (CBER) Regulatory Submissions in Electronic Format for CBER-Regulated Products
  
  	
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    PrintTo 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):

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

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 ListingAdditional 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

                                                                                  Content current as of:
      05/04/2023
              
              
Regulated Product(s)
		 BiologicsTopic(s)
			  Application & ApprovalsDevelopment & Approval Process (CBER)

          
                        2023 Biological Approvals
          2022 Biological Approvals
          Biological Approvals by Year
          Expanded Access to Experimental Biologics
          Vaccine Development – 101


                        Biologics License Applications (BLA) Process (CBER)
          Investigational New Drug Applications (INDs) for CBER-Regulated  Products
          Device Submissions for CBER-Regulated Products
          Labeling for CBER-Regulated Products
          Master Files for CBER-Regulated Products
          New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
          Formal Meetings for CBER-Regulated Products
 
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