FDA overview

The United States Food and Drug Administration has many responsibilities, including protecting the public health by assuring the safety of drugs and devices. Products relevant to radiation oncologists are regulated in the Center of Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. The Oncology Center of Excellence is an inter-center institute that coordinates the regulatory activities of all three centers pertaining to oncology products. In general, centers are further divided into offices and divisions. Most regulatory decisions are based on the scientific evaluation of clinical and other data submitted to FDA and the judgment of the potential risks and benefits by the scientific review staff within the individual divisions. The regulations pertaining to the FDA are in Title 21 of the Code of Federal Regulations, and the FDA publishes guidance documents that explain how the FDA interprets the regulations.