Food and Drug Administration (FDA) Essay -- Food Drug FDA Essays

Food and Drug Administration (FDA)   Ã‚  Ã‚  Ã‚  Ã‚  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.   Ã‚  Ã‚  Ã‚  Ã‚  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 certain standards, FDA protects consumers and enables them to know what they are buying. In deciding whether to approve new drugs, FDA does not itself do research, but rather examines the results of studies done by the manufacturer. The agency must determine that the new drug produces the benefits its supposed to without causing side effects that would outweigh the benefits.   Ã‚  Ã‚  Ã‚  Ã‚  In 1992, the U.S. Congress passed the Prescription Drug User Fee Act. This legislation provided additional resources ... ...f the drugs should be approved. Once the FDA approves the drug, it does not mean it is perfectly safe. Some medicine may have side effects, but the FDA considers both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling outlines the benefits and risk reported in the tested population. For a drug to be approved by CDER, by current law, all new drugs need proof that they are effective and safe before they can be approved for marketing. CDER decides as quickly as a thorough evaluation allows. When a proposed drug’s benefit outweighs know risk, CDER considers it safe enough to approve. Once a drug gets the CDER approval, the drug is on the market as soon as the firm gets its production distribution system going.   Ã‚  Ã‚  Ã‚  Ã‚  The FDA is prohibited from releasing information on any medicine under development, review or pending approval unless the information has been in the public. The FDA has no legal authority to investigate or control the prices charged for marketed drugs. Manufacturers, distributors and retailers establish these prices. FDA recognizes the other factors beyond its purview, including insurance coverage and drug pricing.