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U.S. drug regulation

Prescription drugs Over-the-counter drugs Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption Government agencies United States Department of Health and Human Services Food and Drug Administration Drug Enforcement Administration National Institutes of Health Center for Drug Evaluation and Research Process Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs Non-governmental organizations Institute of Medicine Research on Adverse Drug events And Reports

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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 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. 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. Steven K. Galson, is now the acting Surgeon General.

Role of Advisory Committees

• Pharmaceutical Science and Clinical Pharmacology
• Psychopharmacologic Drugs

References

External links

• CDER website.

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Wikipedia content modification information:

• This page was last modified on 18 September 2008, at 20:28.

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