Food and Drug Administration (FDA) The FDA has many responsibilities that include overseeing the production of safe foods and the manufacturing of safe and effective drugs and medical devices. The FDA is responsible for protecting the rights and safety of patients in clinical trials of investigational medical products. The FDA must also review and approve the safety and effectiveness of new drugs, biologics, medical devices, and animal drugs in a timely manner. They must monitor the safety and effectiveness of new medical products after they are marketed and act on the information gathered. The FDA is responsible for ensuring that the public has access to truthful, non-misleading product information by: monitoring the promotional activities of drug and device manufacturers and regulating the labeling of all packaged foods. Science is an important part of the FDA organization. The scientific evidence needed to support the FDA's legal cases is prepared by the agency's 2,100 scientists, including 900 chemists and 300 microbiologists, who work in 40 laboratories in the Washington, D.C. area and across the country. Some of these scientists analyze samples to see, for example, whether products are contaminated with illegal substances. Other scientists review test results submitted by companies seeking agency approval for drugs, vaccines, food additives, dyes 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 operates the Engineering and Testing Center, which tests medical devices, radiation-emitting products, and radioactive drugs. Assessing risk, for drugs and medical devices, weighing the risks against the benefits is at the heart of the FDA's public health duties. By ensuring that products and manufacturers meet certain standards, the FDA protects consumers and lets them know what they are buying. When deciding whether to approve new drugs, the FDA does not conduct research, but rather reviews the results of studies conducted by the manufacturer. The agency must determine that the new drug produces the intended benefits without causing side effects that outweigh the benefits. In 1992, the United States Congress passed the Prescription Drug User Fee Act. This legislation provided additional resources… halfway through… for drugs to be approved. Once the FDA approves the drug, that doesn't mean it's perfectly safe. Some medications may have side effects, but the FDA considers both the benefits and risks of all medications before approving them. Additionally, the FDA writes labeling that outlines the benefits and risks reported in the population tested. In order for a drug to be approved by CDER, under current law, all new drugs require evidence that they are effective and safe before they can be approved for marketing. CDER decides as quickly as a thorough assessment allows. When the benefit of a proposed drug outweighs the known risk, CDER considers it safe enough to approve it. Once a drug gets CDER approval, the drug is on the market as soon as the company sets up its manufacturing and distribution system. The FDA is prohibited from releasing information about any drug in development, review, or pending approval unless the information has been made public. The FDA has no legal authority to investigate or monitor the prices charged for marketed drugs. Manufacturers, distributors and retailers set these prices. The FDA recognizes the others.