Center for Drug Evaluation and Research
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The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. CDER reviews New Drug Applications to ensure that the drugs are safe and effective. It is one of five Centers at the United States Food and Drug Administration. Its primary objective is to ensure that all prescription and over-the-counter (OTC) medications are safe and effective.
The 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.
Within the CDER "Review teams" of around 1,300 employees approve new drugs. Additionally, the CDER employs a "safety team" has 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.
The current Director is Dr. Steve Galson.
Role of Advisory Committees
CDER submits requests for advice to many different Advisory Committees. These committees, composed of experts in their respective fields, provide non-binding advice to CDER about the advisability of approving particular drugs.
There are sixteen advisory committees functioning within CDER:
- Anesthetic and Life Support Drugs
- Anti-Infective Drugs
- Antiviral Drugs
- Arthritis Drugs
- Cardiovascular and Renal Drugs
- Dermatologic and Ophthalmic Drugs
- Drug Safety and Risk Management
- Endocrinologic and Metabolic Drugs
- Gastrointestinal Drugs
- Nonprescription Drugs
- Onologic Drugs, also known as the Oncology Drug Advisory Committee
- Peripheral and Central Nervous System Drugs
- Pharmaceutical Science and Clinical Pharmacology
- Psychopharmacologic Drugs
- Pulmonary-Allergy Drugs
- Reproductive Health Drugs
References
External links
Acknowledgement and Attribution Regarding Sources of Content
Some of the initial content on this page may be incorporated in part from copyleft sources in the public domain including wikis such as Wikipedia and AskDrWiki. Drug information for patients came from the The National Library of Medicine. Infectious disease information may have come from the Centers for Disease Control (CDC). Differential Diagnoses are drawn from clinicians as well as an amalgamation of 3 sources: 1.The Disease Database; 2. Kahan, Scott, Smith, Ellen G. In A Page: Signs and Symptoms. Malden, Massachusetts: Blackwell Publishing, 2004:3; 3. Sailer, Christian, Wasner, Susanne. Differential Diagnosis Pocket. Hermosa Beach, CA: Borm Bruckmeir Publishing LLC, 2002:7 .
