Office of Global Regulatory Operations and Policy
The Office of Global Regulatory Operations and Policy, comprises the Office of Regulatory Affairs and the Office of International Programs. The Deputy Commissioner for Global Regulatory Operations and Policy 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.
FDA seeks listing under EU’s Falsified Medicines Directive – Statement Date: January 24, 2013
Speeches and Testimony
"Counterfeit Drugs: Fighting Illegal Supply Chains"
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, February 27, 2014