U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Resources for You (Biologics)
  4. Industry (Biologics)
  1. Resources for You (Biologics)
vials and test tubes

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

Sub-Topic Paragraphs

Paragraph Header
Follow CBER

Contact Point
Division of Manufacturers Assistance and Training
Office of Communication, Outreach and Development
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

(800) 835-4709
(240) 402-8020

Hours Available

Food and Drug Administration
Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave
Silver Spring, MD 20993
United States

For Updates on Twitter follow

Contact Point Twitter


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

Subscribe for CBER Updates

Get e-mail updates on What’s New at CBER!

Back to Top