Development & Approval Process (CBER)
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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. - 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). - 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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Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
(800) 835-4709
(240) 402-8010
For Updates on Twitter, follow @fdacber