Howard Sklamberg

Deputy commissioner

Howard Sklamberg is FDA’s deputy commissioner for global regulatory operations and policy, and he is the directorate comprising the Office of Regulatory Affairs and the Office of International Programs. Sklamberg provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. Sklamberg played leadership roles in global drug supply chain security, pharmacy compounding oversight, pharmaceutical quality, and expanded cooperation with international regulatory partners. Sklamberg has degrees from Harvard Law School, Yale University, and Fletcher School of Law and Diplomacy.

Tue, 06/21/2016 - 17:05
The FDA Forms New Partnerships to Ensure Product Safety Creating global alliances to meet the challenge
Tue, 06/21/2016 - 17:05
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores. In fiscal year 2015,…
When Inspections and Regulations Leave Quality Lacking, Try This A Case for Quality is changing medical device manufacturers focus and FDA’s approach
Wed, 12/02/2015 - 16:33
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified…
Protecting the Global Drug Supply Implementing Title VII of the FDASIA
Wed, 07/23/2014 - 16:35
Since July 9, 2012, when President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), a group of colleagues and I have had an urgent mission: implement Title VII of the statute. This section gave the FDA new authority…
Building Expertise and Crossing Boundaries to Improve Oversight Keeping pace with the scientific innovation and global expansion of markets is an FDA priority
Mon, 06/02/2014 - 12:49

To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world. As the Food and Drug Administration’s Deputy Commissioner for…