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
A key aspect of globalization is the ever-increasing volume and complexity of imports coming to America’s shores. As the chart above documents, last fiscal year, FDA oversaw more than 34 million shipments of FDA-regulated products, up from just 15 million shipments a decade ago. These products come from more than 150 nations, are handled by 130,000 importers, and are manufactured, processed, or packaged at more than 300,000 foreign facilities.
GO Facts at a Glance (January 2017)
Total employees: 5,065
- ORA: 4,899 employees
- OIP: 154 employees including staff in Belgium, China, Chile, Costa Rica, India, Mexico, and the United Kingdom.
- ORA conducted more than 16,100 domestic inspections in FY 2016. That amounts to roughly 1,340 inspections a month -- or about 44 inspections every day of the week.
- Our labs analyzed approximately 35, 220 samples in FY 2016 – or more than 78 samples analyzed every single day of the week.
- OCI, in Fiscal Year 2016, made 257 arrests, won 274 convictions, and secured nearly $375 million in fines, restitutions, asset seizures and forfeitures.
- Overseas, our personnel conducted 3, 512 inspections in FY 2016, in locations ranging from China to Mexico to India.
- GO has helped achieve the signing of more than 148 International Arrangements with more than 43 nations and multilateral partners regarding FDA's product quality and safety efforts.
Presentations and Testimony
- Remarks to the Food and Drug Law Institute's 2016 Annual Conference
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, May 6, 2016
Remarks to the Food and Drug Law Institute's Global Business Conference
Dara Corrigan, J.D. Associate Commissioner for Global Regulatory Policy, March 16, 2016
Remarks to the World Spice Congress 2016
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, February 27, 2016
Third Annual Eric M. “Rick” Blumberg Memorial Luncheon Address, Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, December 10, 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
FDA Voice Blogs
Trade Alert: FDA Issues New Import Data Requirements
Howard Sklamberg, J.D. November 30, 2016
SCORE at Six Months: Meeting the Challenge of Complex Recalls
Stephen Ostroff, M.D., and Howard Sklamberg, J.D. October 25, 2016
- First Major FSMA Compliance Dates: Landmarks and Learning Experiences
Stephen Ostroff, M.D., and Howard Sklamberg, J.D. September 19, 2016
- Addressing Global Challenges through Transatlantic Cooperation
Howard Sklamberg, J.D., Lou Valdez, and Donald Prater, July 19, 2016
- Globalization and FDA's New Partnerships to Ensure Product Safety
Howard Sklamberg, J.D. June 7, 2016
A FSMA Update for Our Stakeholders in India
Howard Sklamberg, J.D. March 8, 2016
FDA Enforcement: Protecting Consumers and Enhancing Public Confidence
Howard Sklamberg, J.D. and Michael R. Taylor, J.D. December 21, 2015
The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients
Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W. November 12, 2015