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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)
          2022 Biological ApprovalsDevelopment & Approval Process (CBER) 2022 Biological Approvals
  
  	
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    PrintThe Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities.  See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks.

**Biologics License Applications and Supplements**

New BLAs (except those for blood banking), and BLA supplements that are expected to significantly enhance the public health (e.g., for new/expanded indications, new routes of administration, new dosage formulations and improved safety).

2022 Biological License Application Approvals
	2022 Biological License Application Supplement Noteworthy Approvals
	2022 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals**Other Applications Approved or Cleared by the Center for Biologics Evaluation and Research (CBER)**

Medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products.

2022 Biological Device Application ApprovalsKey Resources

Development & Approval Process (CBER)
	Biologics Products & Establishments
	Transfer of Therapeutic Products to the Center for Drug Evaluation and Research - Archived

                                                                                  Content current as of:
      02/17/2023Development & 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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