The Office of Global Regulatory Operations and Policy (GO),[1] also known as the Office of Regulatory Affairs (ORA),[2] is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer.
[16] Some are also commissioned officers of the Public Health Service,[17] but this does not generally affect day-to-day duties.
Compliance Officers handle the administrative authorities used in inspections, such as issuing Warning Letters.
[18] They also organize civil litigation (such as a seizure or injunction) which is brought to the courts by the United States District Attorneys.
The field science laboratories were historically part of the FDA districts infrastructure but are now independent entities.