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Office of Global Regulatory Operations and Policy

FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs.

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.[3]

The FDA Office of Regulatory Affairs is responsible for the enforcement of federal legislation and serves in a regulatory capacity to ensure health related products are accurately and informatively represented to the public, effective, and safe.

The Office of Regulatory Affairs has legislative and regulatory authority for the specified health related products:

  • Biologics[4]
  • Cosmetics[5]
  • Dietary Supplements[6]
  • Drugs[7]
  • Foods[8]
  • Medical Devices[9]
  • Radiation-Emitting Electronic Products[10]
  • Tobacco Products[11]
  • Veterinary Products[12]
  1. ^ "Office of Global Regulatory Operations and Policy". U.S. FDA Organization. U.S. Food & Drug Administration.
  2. ^ "Office of Regulatory Affairs". U.S. FDA Organization. U.S. Food & Drug Administration. 22 September 2021.
  3. ^ "U.S. FDA Regulatory Information". U.S. Food & Drug Administration. 23 April 2019.
  4. ^ "U.S. FDA Vaccines, Blood & Biologics". U.S. Food & Drug Administration. 24 February 2023.
  5. ^ "U.S. FDA Cosmetics". U.S. Food & Drug Administration. 20 December 2022.
  6. ^ "U.S. FDA Dietary Supplements". U.S. Food & Drug Administration. 6 March 2023.
  7. ^ "U.S. FDA Drugs". U.S. Food & Drug Administration. 3 March 2023.
  8. ^ "U.S. FDA Food". U.S. Food & Drug Administration. 8 March 2023.
  9. ^ "U.S. FDA Medical Devices". U.S. Food & Drug Administration. March 2023.
  10. ^ "U.S. FDA Radiation-Emitting Products". U.S. Food & Drug Administration. 5 August 2022.
  11. ^ "U.S. FDA Tobacco Products". U.S. Food & Drug Administration. 8 March 2023.
  12. ^ "U.S. FDA Animal & Veterinary". U.S. Food & Drug Administration. 10 March 2023.

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