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  1. Resources for You (Biologics)
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CBER’s Policies, Procedures, and Review Resources

This webpage provides important resources related to the regulatory framework of products regulated by CBER, including policies, procedures, and review resources.

CBER reviews applications for new products, new indications for already approved products, and product-related changes. This requires evaluating submitted scientific and clinical data to determine whether the product meets CBER's standards for approval. After a thorough assessment of the data, CBER makes a decision based on the risk-benefit for the intended population and the product's intended use. CBER's authority resides in the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act.

Laws, Regulations, Guidances and Other Information

Establishment Registration

Product Development

Product Application and Approval

Postmarketing, Compliance and Enforcement

More Information

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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

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