DBpedia – Linked Data Fragments

Matches in DBpedia 2016-04 for { ?s ?p "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 new and generic 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 reviews New Drug Applications to ensure that the drugs are safe and effective. 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.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. The FDA requires a four phased series of clinical trials, with phase three being the largest and usually requiring 1,000-3,000 patients.Janet Woodcock is the director of CDER."@en }

• Center_for_Drug_Evaluation_and_Research abstract "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 new and generic 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 reviews New Drug Applications to ensure that the drugs are safe and effective. 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.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. The FDA requires a four phased series of clinical trials, with phase three being the largest and usually requiring 1,000-3,000 patients.Janet Woodcock is the director of CDER.".