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 (September 2, 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.
- Along with the Office of Foods and Veterinary Medicine, GO has announced an operational plan to implement FSMA, the Food Safety and Modernization Act.
- GO has helped achieve the signing of 79 Memorandums of Understanding and Cooperative Agreements with 27 nations regarding FDA's product quality and safety efforts.
- GO contracts with its state partners in the performance of approximately 20,000 food, feed, drug and device inspections annually in programs that reach all fifty states.
Presentations and Testimony
Keynote Speech, Partnership for Safe Medicines
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, September 18, 2014
Glenn W. Kilpatrick Memorial Address, Association of Food and Drug Officials
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, June 22, 2014
- 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 Blogs
FDA's Program Alignment Addresses New Regulatory Challenges
Margaret A. Hamburg, M.D. October 7, 2014
Reflecting on New Food Protections in the Wake of PCA Convictions
Howard Sklamberg, J.D. and Michael R. Taylor September 25, 2014
- On the Road from Mexico: A Model for Regulatory Cooperation
Margaret A. Hamburg, M.D. July 24, 2014
- Protecting the Global Drug Supply: FDASIA Title VII
Howard Sklamberg, J.D. July 10, 2014
- Ensuring Pharmaceutical Quality Through International Engagement
Howard Sklamberg, J.D. May 12, 2014
- Building Expertise and Crossing Boundaries to Improve Oversight
Howard Sklamberg, J.D. May 5, 2014
- We’re Reinventing Ourselves to Keep Your Food Safe
Michael R. Taylor and Howard Sklamberg, J.D. May 2, 2014
- Visiting India: The Importance of Biomedical Research and Quality
Margaret A. Hamburg, M.D. February 21, 2014
- Quality: A Recurring Theme During My Visit to India
Margaret A. Hamburg, M.D. February 14, 2014
- Visiting India: Sharing a Vision for Strengthening Food and Medical Product Safety
Margaret A. Hamburg, M.D. February 11, 2014
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