Resources for You (Biologics)

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues.

Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

Audience specific resources pages are focused on information that a specific type of user - such as a Consumer - may want to find. It is not intended to be an all-inclusive list, but instead serves as a guide to key information. We appreciate feedback about what content you would find most useful on these resource pages.

Audience Specific Resources for Biologics Information

• Consumers (Biologics)
• Healthcare Providers (Biologics)
• Industry (Biologics)

Audience Specific Resources for General FDA Information

• For Consumers
• For Industry
• For Federal, State, and Local Officials
• For Health Professionals

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Related Information

• Drug Master Files for CBER-Regulated Products

 

• Resources For You:
  • Consumers (Biologics)
  • Healthcare Providers (Biologics)
  • Industry (Biologics)
  • About the Center for Biologics Evaluation and Research (CBER)
• Recalls & Alerts:
  • Recalls (Biologics)
  • CBER-Regulated Products: Shortages and Discontinuations
  • Report a Problem to the Center for Biologics Evaluation & Research
• Approvals & Clearances:
  • Biologics Products & Establishments

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Food and Drug Administration
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Food and Drug Administration

Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave
Silver Spring, MD 20993
United States

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