Transcript FDA`s Mission

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
– Distributed in a timely manner
What is CBER?
• Biologic Products:
– Blood
– Vaccines
– Allergenic’s
– Cellular and Gene Therapy
– Tissues
– Devices
Blood
• Regulates
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Collection
Components
Equipment
Screening tests
Establishments
Developing standards
Promote supplies
Vaccines
• Regulates
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Safety
Effectiveness
Side effects
Incidence
Allergenic’s
• Allergen Patch
Tests
– Made from:
• Chemicals
• Naturally
occurring
substances
• Allergenic
Extracts
– Made from:
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Pollens
Molds
Venoms
Hair
Foods
Cellular and Gene Therapy
• Regulate
– Genetic material and cellular
components used to treat
• Faulty genes
• Diseases
Pancreatic Islet Transplantation to
Treat Type I Diabetes
Tissue
• Regulate:
– Over 1000 human tissues that are
prepared and processed for
transplantation
• Skin
• Bones
• Cornea
• Ligaments
• Tendons
Devices
• Regulates:
– Collection
– Processing
– Testing
– Storage
– Redistribution
– CBER - Devices
Regulated by
CBER
FDA’s Mission
• “The FDA mission is to protect the
general publics health by ensuring…”
– Safety
– Efficacy
– Security
CBER Attributions
• CBER contributes to the FDA’s
mission by regulating efforts through
– monitoring
– investigating
– research
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
Questions???