Biological Products

Background

Biological products often represent the cutting edge of medical science and research. Also known as biologics, these products replicate natural substances such as enzymes, antibodies, or hormones in our bodies.

Biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. Biologics are made from a variety of natural resources—human, animal, and microorganism—and may be produced by biotechnology methods.

What biological products does FDA regulate?

The Center for Biologics Evaluation and Research (CBER) within FDA regulates a wide range of biological products, including

  • allergenic extracts (e.g. for allergy shots and tests)
  • blood and blood components
  • gene therapy products
  • devices and test kits
  • human tissue and cellular products used in transplantation
  • vaccines

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