Center For Biologics Evaluation and Research (CBER)

A Center For Biologics Evaluation and Research (CBER) is a Food And Drug Administration's division that is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products.

• Example(s):
  • …
• Counter-Example(s):
  • Center For Drug Evaluation and Research,
  • Center For Devices and Radiological Health,
  • Center For Food Safety and Applied Nutrition,
  • Center For Tobacco Products,
  • Center For Veterinary Medicine,
  • National Center For Toxicological Research.
• See: Clinical Trial, Good Clinical Practice, U.S. Department of Health And Human Services, Peter Marks (Physician), Biologic Medical Product, Vaccine, Probiotic, Blood Product, Cell Therapy, Gene Therapy, Monoclonal Antibodies.

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References

2021

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Center_for_Biologics_Evaluation_and_Research Retrieved:2021-12-25.
  • The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies). Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).

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