Center for Drug Evaluation and Research
Encyclopedia
The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research
. The center reviews applications for new and generic pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription
, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.
CDER reviews New Drug Applications to ensure that the drugs are safe and effective. Its primary objective is to ensure that all prescription
and over-the-counter (OTC) medications are safe and effective when used as directed.
CDER receives considerable public scrutiny, and thus implements processes that tend toward objectivity and tend to isolate decisions from being attributed to specific individuals. In keeping with this, reviews are generally staffed by teams that are intended to come to consensus on decisions. The decisions on approval will often make or break a small company's stock price (e.g., Martha Stewart
and Imclone), so the markets closely watch CDER's decisions.
The center has around 1,300 employees in "Review teams" that evaluate and approve new drugs. Additionally, the CDER employs a "safety team" with 72 employees to determine whether new drugs are unsafe or present risks not disclosed in the product's labeling.
The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year. The FDA requires a four phased series of clinical trials, with phase three being the largest and usually requiring 1,000-3,000 patients.
Janet Woodcock, M.D. is the director of CDER.
.
In 1987, under Commissioner Frank Young
, CDER and the Center for Biologics Evaluation and Research
(CBER) were split into their present form. The two groups were charged with enforcing different laws and had significantly different philosophical and cultural differences. At that time, CDER was more cautious about approving therapeutics and had a more adversarial relationship with the industry. 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.
In 2002, the FDA transferred a number of biologically produced therapeutics to CDER.
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is one of six main centers for the U.S. Food and Drug Administration , which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Dr. Karen Midthun, M.D...
. The center reviews applications for new and generic pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription
Medical prescription
A prescription is a health-care program implemented by a physician or other medical practitioner in the form of instructions that govern the plan of care for an individual patient. Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist or other therapist....
, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.
CDER reviews New Drug Applications to ensure that the drugs are safe and effective. Its primary objective is to ensure that all prescription
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
and over-the-counter (OTC) medications are safe and effective when used as directed.
CDER receives considerable public scrutiny, and thus implements processes that tend toward objectivity and tend to isolate decisions from being attributed to specific individuals. In keeping with this, reviews are generally staffed by teams that are intended to come to consensus on decisions. The decisions on approval will often make or break a small company's stock price (e.g., Martha Stewart
Martha Stewart
Martha Stewart is an American business magnate, author, magazine publisher, and television personality. As founder of Martha Stewart Living Omnimedia, she has gained success through a variety of business ventures, encompassing publishing, broadcasting, and merchandising...
and Imclone), so the markets closely watch CDER's decisions.
The center has around 1,300 employees in "Review teams" that evaluate and approve new drugs. Additionally, the CDER employs a "safety team" with 72 employees to determine whether new drugs are unsafe or present risks not disclosed in the product's labeling.
The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year. The FDA requires a four phased series of clinical trials, with phase three being the largest and usually requiring 1,000-3,000 patients.
Janet Woodcock, M.D. is the director of CDER.
History
In 1982, when the beginning of the biotechnology revolution blurred the line between a drug and a biologic, the Bureau of Drugs was merged with the FDA's Bureau of Biologics to form the Center for Drugs and Biologics during an agency-wide reorganization under Commissioner Arthur Hayes. This reorganization similarly merged the bureaus responsible for medical devices and radiation control into the Center for Devices and Radiological HealthCenter for Devices and Radiological Health
The Center for Devices and Radiological Health is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices...
.
In 1987, under Commissioner Frank Young
Frank Edward Young
Frank Edward Young was a U.S. administrator and physician. He served as commissioner of Food and Drug Administration between 1984 and 1989. Dr. Young is now a senior partner at The Cosmos Alliance, a Maryland-based venture capital firm....
, CDER and the Center for Biologics Evaluation and Research
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is one of six main centers for the U.S. Food and Drug Administration , which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Dr. Karen Midthun, M.D...
(CBER) were split into their present form. The two groups were charged with enforcing different laws and had significantly different philosophical and cultural differences. At that time, CDER was more cautious about approving therapeutics and had a more adversarial relationship with the industry. The growing crisis around HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
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
Tissue plasminogen activator
Tissue plasminogen activator is a protein involved in the breakdown of blood clots. It is a serine protease found on endothelial cells, the cells that line the blood vessels. As an enzyme, it catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for clot breakdown...
) led to the split.
In 2002, the FDA transferred a number of biologically produced therapeutics to CDER.