The United States Food and Drug Administration (FDA) is organized into several centers that are responsible for different areas of regulatory oversight. The FDA centers include:
- Center for Drug Evaluation and Research (CDER): The CDER is responsible for the review and approval of new drugs for use in the United States, as well as the ongoing monitoring of approved drugs to ensure their continued safety and efficacy.
- Center for Biologics Evaluation and Research (CBER): The CBER is responsible for the review and approval of biological products, such as vaccines, blood products, and allergenics, for use in the United States.
- Center for Devices and Radiological Health (CDRH): The CDRH is responsible for the review and approval of medical devices, as well as the ongoing monitoring of approved devices to ensure their continued safety and effectiveness.
- Center for Food Safety and Applied Nutrition (CFSAN): The CFSAN is responsible for ensuring the safety of the nation’s food supply by setting and enforcing food safety standards and responding to foodborne illness outbreaks.
- Center for Tobacco Products (CTP): The CTP is responsible for regulating the manufacture, sale, and distribution of tobacco products in the United States, with the aim of reducing the harm caused by tobacco use.
- National Center for Toxicological Research (NCTR): The NCTR conducts research and testing to support the FDA’s regulatory mission, with a focus on the safety of foods, drugs, and medical devices.
- Office of Regulatory Affairs (ORA): The ORA is responsible for enforcing FDA regulations and ensuring that regulated products are in compliance with federal law.
These centers work together to carry out the FDA’s mission of protecting and promoting public health by ensuring the safety, efficacy, and security of the products that the agency regulates. Each center focuses on a specific area of regulation and is staffed by scientists, regulatory professionals, and other specialists with expertise in that area.
You may be interested in the programs below: