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

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

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

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

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

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

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.

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

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

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???