Food and Drug Administration and Drugs

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Business Law
October 11, 2000

The FDA has many responsibilities which include overseeing the production of safe foods and the manufacture of safe and effective drugs and medical devices. The FDA has responsibility for protecting the rights and safety of patients in the clinical trials of investigation medical products. The FDA also has to review and approve in a timely manner the safety and efficiency of new drugs, biologics, medical devices, and animal drugs. They have to monitor the safety and effectiveness of new medical products after they are marketed and acting on the information collected. The FDA is responsible for seeing that the public has access to truthful and non-misleading product information by: monitoring the promotional activities of drug and device manufacturers, and regulating the labeling of all packaged foods.

Science is a big part of the FDA organization. The scientific evidence needed to back up FDAs legal cases is prepared by the agencies 2,100 scientist, including 900 chemist and 300 microbiologist, who work in 40 laboratories in the Washington, D.C., area and around the country. Some of these scientist analyze samples to see, or example if products are contaminated with illegal substances. Other scientist review test results submitted by companies seeking agency approval for drugs, vaccines, food additives, coloring agents and medical devices. The FDA also operates the National Center for Toxicological Research. They investigate the biological effects of widely used chemicals. The agency also runs the Engineering and Analytical Center, which test medical devices, radiation-emitting products, and radioactive drugs. Assessing risk, for drugs and medical devices, weighing risks against benefits is at the core of FDAs public health protection duties. By ensuring that products and producers meet

Goins II
certain standards, FDA protects consumers and enables them to know what they are buying. In deciding...
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