Center for Biologics Evaluation and Research

CBERBureau of BiologicsCenter for Biologics Evaluation and Research (CBER)Laboratory of Biologics Control
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S.wikipedia
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Food and Drug Administration

FDAU.S. Food and Drug AdministrationUnited States Food and Drug Administration
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services.
The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents.

Center for Drug Evaluation and Research

CDERUS
Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research.

Biopharmaceutical

biologicsbiopharmaceuticalsbiologic
The current Director of CBER is Dr. Karen Midthun, M.D. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies).
In the United States, biologics are licensed through the biologics license application (BLA), then submitted to and regulated by the FDA's Center for Biologics Evaluation and Research (CBER) whereas drugs are regulated by the Center for Drug Evaluation and Research.

Jim (horse)

Jimhorse named Jima horse named Jim
CBER's history began with a horse named Jim, a vaccine-contamination scandal that prompted the Biologics Control Act of 1902.
This incident, and a similar one involving contaminated smallpox vaccine, led to the passage of the Biologics Control Act of 1902, which established the Center for Biologics Evaluation and Research.

Biologics Control Act

Biologics Control Act of 1902
CBER's history began with a horse named Jim, a vaccine-contamination scandal that prompted the Biologics Control Act of 1902.
In 1972, biologics regulation was moved to the Food and Drug Administration and later became known as the Center for Biologics Evaluation and Research (CBER).

Kathryn Zoon

*Kathryn Zoon, Director, 1992 to 2002
From 1992 to 2002, Zoon was director of the FDA Center for Biologics Evaluation and Research (CBER).

United States Department of Health and Human Services

Department of Health and Human ServicesU.S. Department of Health and Human ServicesHealth and Human Services
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services.

Vaccine

vaccinesvaccinologyvaccinated
The current Director of CBER is Dr. Karen Midthun, M.D. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies).

Probiotic

probioticsVSL#3beneficial
The current Director of CBER is Dr. Karen Midthun, M.D. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies).

Blood product

blood productsblood componentsblood component
The current Director of CBER is Dr. Karen Midthun, M.D. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies).

Cell therapy

cell therapiescellular therapyallogenic stem therapy
The current Director of CBER is Dr. Karen Midthun, M.D. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies).

Gene therapy

human genetic engineeringgene therapiesgene
The current Director of CBER is Dr. Karen Midthun, M.D. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies).

Monoclonal antibody

monoclonal antibodiesmonoclonalmAb
Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).

Blood

human bloodhematologicaloxygen consumption

HIV

human immunodeficiency virusHIV-positiveHIV positive
The growing crisis around HIV testing and treatment, and an inter-agency dispute between officials from the former Bureau of Drugs and officials from the former Bureau of Biologics over whether to approve Genentech's Activase (tissue plasminogen activator), led to the split.

Public Health Service Act

Public Health Service Act of 19441944Alcoholic and Narcotic Addict Rehabilitation Amendments of 1968
As of July 2006 CBER's authority resides in sections 351 and 361 of the Public Health Service Act and in various sections of the Food, Drug and Cosmetic Act.

Federal Food, Drug, and Cosmetic Act

Food, Drug, and Cosmetic ActFood, Drug and Cosmetic ActFederal Food, Drug and Cosmetic Act
As of July 2006 CBER's authority resides in sections 351 and 361 of the Public Health Service Act and in various sections of the Food, Drug and Cosmetic Act.

Commerce Clause

interstate commerceInterstate Commerce Clauseinterstate
Section 351 of the Public Health Service Act requires licensure of biological products that travel in interstate commerce in the United States.

United States

AmericanU.S.USA
Section 351 of the Public Health Service Act requires licensure of biological products that travel in interstate commerce in the United States.