About FDA

What is a biological product?

Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include

  • vaccines
  • blood and blood products for transfusion and/or manufacturing into other products
  • allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
  • human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
  • gene therapies
  • cellular therapies
  • tests to screen potential blood donors for infectious agents such as HIV

Page Last Updated: 05/31/2016
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