FDA the United States Food and Drug Administration
The United States Food and Drug Administration (hereinafter referred to as the food and drug Admistraton food and Drug Administration (FDA), belonging to the U. S. Department of health, education and welfare, responsible for the national drug, food, biological products, cosmetic, medicine, medical equipment and diagnosis activities such as management. The FDA under the Bureau of drug, Food Bureau, bureau of veterinary drugs, radiation health bureau, bureau of biological products, medical apparatus and instruments, and diagnostic products bureau and the National Center for toxicological research, regional management mechanism, namely six Bureau (some publications, also known as six Center), a center and a regional management agencies. The Drug Administration (also known as the center for drug evaluation and Research) is responsible for the approval of drugs, with 8 offices and a number of departments. FDA has different regulatory standards for different products, it requires fresh food safety, safety and non-toxic cosmetics, medicines, medical devices, biological and animal products, effective and safe.
In outside the United States in the production of food, health care products, additives listed, without FDA approval, as long as in prior to listing for the FDA registration entry inspection can be, generally a few weeks to a few months, costs thousands to three million dollars. But the FDA is requiring manufacturers to ensure food hygiene and safety standards, and not regular spot checks, if does not conform to the standards can be banned from the market.
FDA requires all foreign manufacturers (except cosmetics) to enter the U.S. market before the production facilities and product registration, so that the entire FDSA product tracking and monitoring. Illegal and fraudulent or misleading enterprises will be punished, and even by the prosecution.
FDA for drugs, medical equipment management is the most stringent. It will review the manufacturers to provide all the results of the experiment, including safety data (in vitro), human and animal experimental data, pharmaceutical analysis and data to produce a record, and facilities to carry out field visits, the whole process is very rigorous and time-consuming.