CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

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CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
By Wysteria Hart Sahar Mohammadi
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Who is CBER?

• Governed by
• Section 351 of the Public Health Service Act
• Sections of the Food Drug and Cosmetics Act

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What is CBER?

• Regulate biologic products
• Safe for use
• Effective
• Distributed in a timely manner

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What is CBER?

• Biologic Products
• Blood
• Vaccines
• Allergenics
• Cellular and Gene Therapy
• Tissues
• Devices

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Blood

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

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Vaccines

• Regulates
• Safety
• Effectiveness
• Side effects
• Incidence

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Allergenics

• Allergenic Extracts
• Made from
• Pollens
• Molds
• Venoms
• Hair
• Foods

• Allergen Patch Tests
• Made from
• Chemicals
• Naturally occurring substances

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Cellular and Gene Therapy

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

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Tissue

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

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Devices

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

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FDAs Mission

• The FDA mission is to protect the general
  publics health by ensuring
• Safety
• Efficacy
• Security

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CBER Attributions

• CBER contributes to the FDAs mission by
  regulating efforts through
• monitoring
• investigating
• research

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Work Cited

• U.S. Food and Drug Administration
• Center for Biologics Evaluation and Research _at_
• http//www.fda.gov/cber
• Also
• Google images _at_
• http//www.google.com

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Questions???