Center For Drug Evaluation and Research (CDER)
A Center For Drug Evaluation and Research (CDER) is a FDA's division that monitors most drugs as fedined by Food, Drug, and Cosmestic Act.
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- See: Drug Development Clinical Trial, Good Clinical Practice, Good Manufacturing Practice, Medical Prescription, Martha Stewart, Imclone.
References
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Center_for_Drug_Evaluation_and_Research Retrieved:2021-12-25.
- 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 brand name, generic, and over the counter 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 receives considerable public scrutiny, and thus implements processes that tend toward objectivity and tend to isolate decisions from being attributed to specific individuals. 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.
Janet Woodcock is the director of CDER.
- 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 brand name, generic, and over the counter 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.