Office of Global Regulatory Operations and Policy
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.
GO Facts at a Glance (July 15, 2014)
Total employees: 4,450
- ORA: 4,300 -- includes 1,810 investigators, 850 lab analysts, 222 OCI Special Agents. Locations include 227 field offices and 13 laboratories.
- OIP: 154 employees including staff in Belgium, China, Chile, Costa Rica, India, Mexico, South Africa, and the United Kingdom.
- ORA conducted more than 16,700 domestic inspections in FY 2013. That amounts to roughly 1,391 inspections a month -- or more than 46 inspections every day of the week.
- Our labs analyzed 6,800 samples in the first three months of this year – or more than 74 samples analyzed every day of the week.
- OCI, in the past nine months, has made 254 arrests, won 204 convictions, and secured $2.1 billion in fines and restitutions.
- Overseas, our personnel conducted 2,840 inspections in FY 2013, in locations ranging from China to South Africa to Morocco to India.
Presentations and Testimony
- Food Safety Modernization Act Operational Strategy (PDF - 209KB)
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, ABA Section of Litigation Food and Supplements Workshop, June 5, 2014
Medical Product Quality(PDF - 270KB)
Howard Sklamberg, J.D. Deputy Commissioner for Global Regulatory Operations and Policy, March 11, 2014
"Counterfeit Drugs: Fighting Illegal Supply Chains"
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, February 27, 2014
- FDA Voice Blog- On the Road from Mexico: A Model for Regulatory Cooperation
Margaret A. Hamburg, M.D. July 24, 2014
- FDA Voice Blog- Protecting the Global Drug Supply: FDASIA Title VII
Howard Sklamberg, J.D. July 10, 2014
- FDA Voice Blog- Ensuring Pharmaceutical Quality Through International Engagement
Howard Sklamberg, J.D. May 12, 2014
- FDA Voice Blog- Building Expertise and Crossing Boundaries to Improve Oversight
Howard Sklamberg, J.D. May 5, 2014
- FDA Voice Blog- We’re Reinventing Ourselves to Keep Your Food Safe
Michael R. Taylor and Howard Sklamberg, J.D. May 2, 2014
- FDA Voice Blog- Visiting India: The Importance of Biomedical Research and Quality
Margaret A. Hamburg, M.D. February 21, 2014
- FDA Voice Blog- Quality: A Recurring Theme During My Visit to India
Margaret A. Hamburg, M.D. February 14, 2014
- FDA Voice Blog- Visiting India: Sharing a Vision for Strengthening Food and Medical Product Safety
Margaret A. Hamburg, M.D. February 11, 2014
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