The Office of Global Regulatory Operations and Policy (also known as GO) comprises the Office of Regulatory Affairs and the Office of International Programs. The Deputy Commissioner for GO provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product quality and safety efforts, including global collaboration, global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities.
A fuller explanation of FDA Globalization initiatives can be found on the International Programs - Globalization page
GO Facts at a Glance (September 1, 2015)
Total employees: 4,450
- ORA: 4,300 employees -- includes approximately 1,700 investigators, 650 lab analysts, and 220 OCI Special Agents in locations throughout the U.S.
- OIP: 154 employees including staff in Belgium, China, Chile, Costa Rica, India, Mexico, and the United Kingdom.
- ORA conducted more than 15,400 domestic inspections in FY 2014. That amounts to roughly 1,280 inspections a month -- or 42 inspections every day of the week.
- Our labs analyzed approximately 37,000 samples in FY 2014 – or more than 74 samples analyzed every day of the week.
- OCI, in Fiscal Year 2014, opened 398 cases, made 332 arrests, won 306 convictions, and secured $2.1 billion in fines and restitutions.
- Overseas, our personnel conducted 3,067 inspections in FY 2014, in locations ranging from China to Mexico to India.
- Along with the Office of Foods and Veterinary Medicine, GO is working on an operational plan to implement FSMA, the Food Safety and Modernization Act.
- GO has helped achieve the signing of more than 135 International Arrangements with more than 26 nations regarding FDA's product quality and safety efforts.
- GO contracts with its state partners in the performance, in FY 2014, of approximately 22,000 food, feed, drug and device inspections annually in programs that reach all fifty states.
- GO professionals oversee more than 32 million lines of FDA-regulated products at more than 380 ports of entry and international mail facilities.
Presentations and Testimony
Remarks at the Milan EXPO: World Food Safety and Security Forum
Michael R. Taylor, J.D. Deputy Commissioner for Foods and Veterinary Medicine, September 22, 2015
Remarks at the 18th Annual Meeting of the International Generic Pharmaceutical Alliance
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, September 17, 2015
Remarks at the China Pharmaceutical University
Howard Sklamberg, J.D. Deputy Commissioner for Global Regulatory Operations and Policy, June 2, 2015
Remarks at the United States Pharmacopeial Convention Meeting
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, April 24, 2015
Remarks at the 2015 Annual Conference of the Food and Drug Law Institute
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, April 21, 2015
12th Annual Pharmaceutical Compliance Congress
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, March 3, 2015
FDANews Inspections Summit
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, October 24, 2014
"Counterfeit Drugs: Fighting Illegal Supply Chains"
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, February 27, 2014
FDA Voice Blogs
- Destroying Certain Imported Drugs: A New Rule to Protect Patients
Howard Sklamberg, J.D. and Melinda K. Plaisier September 29, 2015
Welcoming FDA's New Overseas Leaders: FDA's Foreign Posts Provide a Vital Resource for Consumer Protection
Howard Sklamberg, J.D. and Mary Lou Valdez September 14, 2015
A Global Fight Against Dangerous Counterfeit and Unapproved Medical Products: From Operation Pangea to FDA's Global Strategic Framework
Howard Sklamberg, J.D., George Karavetsos, J.D., and Cynthia Schnedar, J.D. June 30, 2015
China’s Pharmaceutical Future – Both Complex and Growing
Howard Sklamberg, Richard Moscicki, M.D., and Alonza Cruse, June 5, 2015
- In a Country Full of Differences, Common Ground
Michael Taylor, Howard Sklamberg, J.D., Camille Brewer, March 27, 2015
- From New Jersey to New Delhi, a Global Focus on Quality
Howard Sklamberg, J.D. and Cynthia Schnedar March 24, 2015
In India, With Our Sleeves Rolled Up
Howard Sklamberg, J.D. and Michael R. Taylor March 18, 2015