Development & Approval Process (CBER)

The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities including the Public Health Service Act and the Food Drug and Cosmetic Act.

• Investigational New Drug Applications (INDs) for CBER-Regulated Products 
  An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
  • Chemistry, Manufacturing, and Controls Development and Readiness (CDRP)
• Expanded Access to Experimental Biologics
  Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA).
• Biologics License Applications (BLA) Process (CBER)
  The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2).
  • Split Real Time Application Review (STAR)
• New Drug Application (NDA) Process (CBER) New Drug Applications (NDAs) are regulated under 21 CFR 314
• Regulatory Submissions in Electronic Format for CBER-Regulated Products

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Related Information

• Combination Products
• Critical Path Initiative

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1-888-INFO-FDA

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Food and Drug Administration

Food and Drug Administration
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Silver Spring, MD 20993
United States

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The latest information from the Center for Biologics Evaluation and Research.