Center for Drug Evaluation and Research

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 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

* [http://www.fda.gov/cder/index.html CDER website] .


Wikimedia Foundation. 2010.

Игры ⚽ Поможем сделать НИР

Look at other dictionaries:

  • Center for Biologics Evaluation and Research — The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services. CBER is responsible for assuring the safety, purity,… …   Wikipedia

  • National Center for Toxicological Research — The National Center for Toxicological Research (NCTR)[1] is the branch of the United States Food and Drug Administration which conducts research to define biological mechanisms of action underlying the toxicity of products regulated by the FDA.… …   Wikipedia

  • Center for Court Innovation — The Center for Court Innovation is a non profit think tank headquartered in New York that helps courts and criminal justice agencies aid victims, reduce crime and improve public trust in justice. [cite web|url=http://www.courtinnovation.org/… …   Wikipedia

  • Drug interaction — A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own. Typically, interaction between drugs come to mind… …   Wikipedia

  • Center for Global Development — Abbreviation CGD Motto Independent research and practical ideas for global prosperity. Formation 2001 Type Think Tank …   Wikipedia

  • Food and Drug Administration — FDA redirects here. For other uses, see FDA (disambiguation). Food and Drug Administration Agency overview Formed 1906 …   Wikipedia

  • U.S. Food and Drug Administration — Infobox Government agency agency name = Food and Drug Administration parent agency = logo width = 200px logo caption = FDA Logo formed = 1906 [cite web|url=http://www.fda.gov/centennial/|title=FDA Centennial 1906 2006|accessdate=2008 09… …   Wikipedia

  • List of clinical research topics — Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. Contents 1 General topics 2 Drug terminology 3 T …   Wikipedia

  • Generic drug — A generic drug (generic drugs, short: generics) is a drug defined as a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended …   Wikipedia

  • Prescription Drug User Fee Act — The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided …   Wikipedia

Share the article and excerpts

Direct link
Do a right-click on the link above
and select “Copy Link”