Center for Drug Evaluation and Research

The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the FDA that monitors most drugs as defined in the FD&C 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 cGMP regulations for pharmaceutical manufacturing, determines which medications require a prescription, monitors advertising of approved medications, and collects and anaylzes safety data about pharmaceuticals that are already on the market.

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CDER reviews New Drug Applications to ensure that the drugs are safe and effective. It is one of the 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 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.

Within CDER "Review teams" of around 1,300 employees 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.

As of December 2007, the position of the Director is empty. The former Director Dr. Steve Galson, is now the acting Surgeon General.

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.

The composition of these advisory committees is sometimes controversial, since it is very rare that CDER does not follow their advice.

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

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References

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