Fda Research Paper

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FDA Drug Approval Process
Tricia Garbuzovas
October 5, 2011
Cassandra Baker
FDA Drug Approval Process Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and
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Product liability laws allow drug users to sue the manufacture, not the FDA, for any adverse drug reactions and side effects. While the FDA oversees drug safety, they do not ensure it. To avoid the costs associated with lawsuits and the risk of a bad name, drug companies do their best to fully, sometimes overly test products before release. “When product liability law attempts to ensure safety already assured by the FDA, prices may be inefficiently high due to liability costs that do not deter manufacturers from producing unsafe products” (Philipson & Sun, 2008, p. 86).
Drug Approval Process The time frame and cost to release a drug for sale into the United States market is enormous. After nearly 20 years and about one billion dollars spent, a drug manufacture can begin to market its product to consumers (Philipson & Sun, 2008). The reason behind these huge numbers is the drug approval process mandated by the Food and Drug Administration. Understanding the testing process will explain the long time frame and huge costs associated with drug approval.
Stages of the Testing Process There are several phases and applications to complete for drug development in the United States. The three basic stages in the testing process are preclinical, clinical, and approval. The first step of preclinical usually lasts anywhere from one to six years. During the preclinical phase, toxicology studies on the ingredients are collected and drug testing

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