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
Are the center for biologics evaluation and research under direction of the FDA

3. What is CBER? Regulate biologic products Safe for use Effective
Distributed in a timely manner
Biologic products are different from most drugs, in that they have been derived from living organisms.
This includes human products or microbes.
Regulation is accomplished through setting standards, research, monitoring, and enforcement

4. What is CBER? Biologic Products: Blood Vaccines Allergenic’s
Cellular and Gene Therapy
Tissues
Devices
Biologic product includes serums, blood, and its products, toxins, antitoxins, or similar products used for the treatment, preventions or cures of human maladies

5. Blood Regulates Collection Components Equipment Screening tests
Establishments
Developing standards
Promote supplies
Collection-from donors to ensure safety to donor and recipient
Components –such as blood clotters, plateletes, etc…
Equipment-used to collect, store, and redistribute. Also equip. that separates
Screening tests-to ensure safety to recipients
Establishments-such as red cross, who collect donated blood
Developing standards-to ensure safety to everyone involved
Promote supplies-by aiding in obtaining adequate supplies

6. Vaccines Regulates Safety Effectiveness Side effects Incidence
Vaccines have aided in a near eradication of childhood diseases such as smallpox, measles, mumps and rubella.
The CBER works in conjunction with the CDC to monitor safety and side effects of vaccines in a program called “the Vaccine Adverse Event Reporting System”
This regulation is in addition to any future AIDS vaccines

7. Allergenic’s Allergenic Extracts Allergen Patch Tests Made from:
Pollens
Molds
Venoms
Hair
Foods
Allergen Patch Tests
Made from:
Chemicals
Naturally occurring substances
2 types of allergy tests-the allergen patch test and allergenic extracts
Allergen patch tests are used to determine the origin of the allergy

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
No gene therapy products have yet been approved, however there is a lot of research and development being submitted to the FDA
This research could potentially produce cures for cancers, genetics disorders, protection from virus’s, and heart disease’s.

9. Tissue
Regulate:
Over 1000 human tissues that are prepared and processed for transplantation
Skin
Bones
Cornea
Ligaments
Tendons
An example of a facility you may be familiar with, that is regulated by the CBER is cryolife, here in Kennesaw.
organs, such as kidney, liver, heart, lung, and pancreas are not regulated by the CBER, but by the Federal Health Resources Services Administration
Also regulates xenotransplantation which is transplantation using non-human derived cells, tissues and organs

10. Devices Regulates: Collection Processing Testing Storage
Redistribution
CBER - Devices Regulated by CBER
Collection – cells, cellular products, tissue, blood, and blood products
Processing
Testing-HIV/AIDS testing kits
Storage-licensed blood, blood components, and cellular products
Redistribution-medical equipment used in procedures for safety

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

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
Also
Google

14. Questions???