ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Center For Biologics Evaluation and Research (CBER)

The FDA successor to the Bureau of Biologics is responsible for ensuring the safety of this nation’s entire blood supply and the products derived from it; the production and approval of safe and effective of child hood vaccines, including any future AIDS vaccines; the proper oversight of human tissue for transplantation; an adequate and safe supply of allergenic materials and anti-toxins; the safety and efficacy of biological therapeutics, including an exciting new array of biotechnology-derived products used to treat diseases such as cancer and AIDS.

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