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

Food and Drug Administration (FDA)The FDA has many responsibilities which include overseeing the production ofsafe foods and the manufacture of safe and effective drugs and aesculapian devices. TheFDA has responsibility for protecting the rights and safe of patients in the clinicaltrials of investigation medical products. The FDA also has to review and approve in atimely manner the safety and efficiency of new drugs, biologics, medical devices, andanimal drugs. They have to monitor the safety and effectiveness of new medicalproducts after they are marketed and acting on the information collected. The FDA isresponsible for seeing that the creation has access to truthful and non-misleading productinformation by monitoring the promotional activities of drug and device manufacturers,and regulating the labeling of tout ensemble packaged foods. Science is a tumid part of the FDA organization. The scientific evidence needed toback up FDAs legal cases is prepared by the agencies 2,100 scientist, including 900chemist 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, orexample if products are contaminated with illegal substances. Other scientist reviewtest results submitted by companies seeking theatrical performance approval for drugs, vaccines, foodadditives, coloring agents and medical devices. The FDA also operates the NationalCenter for Toxicological Research. They investigate the biological effects of widelyused chemicals. The agency also runs the Engineering and Analytical Center, whichtest medical devices, radiation-emitting products, and radioactive drugs. Assessingrisk, for drugs and medical devices, weighing risks against benefits is at the core ofFDAs public health protection duties. By ensuring that products and producers meet certain standards, FDA protects consumers and enables them to know what they arebuying. In deciding whether to approve new d rugs, FDA does not itself do research,but rather examines the results of studies done by the manufacturer. The agency must ascertain that the new drug produces the benefits its supposed to without causingside effects that would outweigh the benefits.In 1992, the U.S. Congress passed the Prescription Drug User Fee Act. Thislegislation provided supererogatory resources ... ...f the drugs should be approved. Once the FDA approves the drug, itdoes not mean it is perfectly safe. Some medicine may have side effects, but the FDA considersboth the benefit and risk of solely medication before approval.. In addition, FDA makes the labelingoutlines the benefits and risk reported in the tested population. For a drug to be approved byCDER, by current law, all new drugs need proof that they are effective and safe before they canbe approved for marketing. CDER decides as quickly as a entire evaluation allows. When aproposed drugs benefit outweighs know risk, CDER considers it safe enough to ap prove. Oncea drug gets the CDER approval, the drug is on the market as soon as the firm gets its productiondistribution system going.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 legalauthority to investigate or control the prices charged for marketed drugs. Manufacturers,distributors and retailers establish these prices. FDA recognizes the other factors beyond itspurview, including policy coverage and drug pricing.