Food and Drug Administration (FDA)The FDA has many responsibilities, including overseeing the production of safe foods and the manufacturing of safe and effective drugs and medical devices . The FDA has a responsibility to protect the rights and safety of patients during clinical trials of investigational medical products. The FDA must also timely review and approve the safety and effectiveness of new drugs, biologics, medical devices, and animal drugs. They must monitor the safety and effectiveness of new medical products after they are marketed and act on the information collected. 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 plays an important role in the organization of the FDA. The scientific evidence needed to support FDA's legal filings 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 NationalCenter for Toxicological Research. They study the biological effects of widely used chemicals. The agency also operates the Engineering and Analysis Center, which tests medical devices, radiation-emitting products and radioactive drugs. Risk assessment for drugs and medical devices, balancing risks and benefits, is at the heart of FDA's public health protection duties. By ensuring that products and producers 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 do research itself, but rather looks at the results of studies done by the manufacturer. The agency must determine that the new drug produces the intended benefits without causing side effects that would outweigh the benefits. In 1992, the U.S. Congress passed the Prescription Drug User Fee Act. This legislation provided for additional resources...... middle of paper ...... if the drugs were to be approved. Once the FDA approves the drug, it does not mean it is completely safe. Some medications may have side effects, but the FDA considers both the benefits and risks of all medications before approval. Additionally, the FDA establishes labeling describing the benefits and risks reported in the tested population. For a drug to be approved by CDER, under current law, all new drugs must be proven to be effective and safe before they can be approved for marketing. The CDER decides as quickly as a thorough evaluation allows. When the benefits of a proposed drug outweigh the known risks, CDER considers it safe enough for approval. Once a drug gets CDER approval, it is on the market as soon as the company gets its production and distribution system up and running. The FDA is prohibited from disclosing information about any..