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CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH. By: Wysteria Hart Sahar Mohammadi. Who is CBER?. Governed by: Section 351 of the Public Health Service Act Sections of the Food Drug and Cosmetics Act. What is CBER?. Regulate biologic products Safe for use Effective

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CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

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  1. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH By: Wysteria Hart Sahar Mohammadi

  2. Who is CBER? • Governed by: • Section 351 of the Public Health Service Act • Sections of the Food Drug and Cosmetics Act

  3. What is CBER? • Regulate biologic products • Safe for use • Effective • Distributed in a timely manner

  4. What is CBER? • Biologic Products: • Blood • Vaccines • Allergenic’s • Cellular and Gene Therapy • Tissues • Devices

  5. Blood • Regulates • Collection • Components • Equipment • Screening tests • Establishments • Developing standards • Promote supplies

  6. Vaccines • Regulates • Safety • Effectiveness • Side effects • Incidence

  7. Allergen Patch Tests Made from: Chemicals Naturally occurring substances Allergenic Extracts Made from: Pollens Molds Venoms Hair Foods Allergenic’s

  8. Cellular and Gene Therapy • Regulate • Genetic material and cellular components used to treat • Faulty genes • Diseases Pancreatic Islet Transplantation to Treat Type I Diabetes

  9. Tissue • Regulate: • Over 1000 human tissues that are prepared and processed for transplantation • Skin • Bones • Cornea • Ligaments • Tendons

  10. Devices • Regulates: • Collection • Processing • Testing • Storage • Redistribution • CBER - Devices Regulated by CBER

  11. “The FDA mission is to protect the general publics health by ensuring…” Safety Efficacy Security FDA’s Mission

  12. CBER Attributions • CBER contributes to the FDA’s mission by regulating efforts through • monitoring • investigating • research

  13. Work Cited U.S. Food and Drug Administration: Center for Biologics Evaluation and Research @ http://www.fda.gov/cber Also Google images @ http://www.google.com

  14. Questions???

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