FAQs Web Links for FDA Centers and Offices
CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products...read more
FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions...read more
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.
As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs"...read more
The Center for Food Safety and Nutrition provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics.
- Irradiation Frequently Asked Questions and Answers
- FAQs about FDA's Regulation of Infant Formula
- FAQs about the GRAS Guidance for Industry
- FAQs about FDA’s Investigation into the Salmonella Enteritidis Outbreak Involving the Recall of Shell Eggs
- FAQs about Listeria monocytogenes
- Guidance & Regulatory Information
The Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions...read more
- FAQs about Protecting Kids from Tobacco
- FAQs on the Passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA)
The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)...read more
The National Center for Toxicological Research (NCTR), FDA's internationally recognized research center, plays a critical role in the FDA’s mission. NCTR—in partnership with researchers from elsewhere in FDA, other government agencies, academia, and industry—provides innovative technology, methods development, vital scientific training, and technical expertise. The unique scientific expertise of NCTR is critical in supporting FDA product centers and their regulatory roles.
The Office of International Programs (OIP) is the focal point for the agency’s international efforts. Working with representatives of the various program components, the mission of the agency is accomplished in collaboration with international health and regulatory partners through ongoing communications, both emergency and ad hoc, cooperation on health and regulatory issues, exchanges of public and non-public information and documents, technical cooperation and training, personnel exchanges, and certification of certain products exported to and from the United States...read more
The FDA’s Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA supports the five FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement and executes FDA’s Import Strategy and Food Protection Plans...read more
- Questions and answers on voluntary recall of certain liquid infant’s and children’s Tylenol, Motrin, Zyrtec, and Benadryl products