Howard Sklamberg

Partner
Arnold & Porter LLP
 

Howard Sklamberg, a partner at Arnold & Porter, counsels clients on a wide range of compliance and enforcement issues related to FDA regulation and policy. His experience is rooted in a deep understanding of U.S. and foreign food, drug and medical devices law and policy. His areas of expertise include inspections and warning letters, investigations, civil and criminal enforcement, medical product applications and clinical research, imports, the development of FDA policy and FDA-related legislation, and business transactions involving FDA-regulated companies.

Prior to entering private practice, Mr. Sklamberg held a variety of roles at the FDA from 2010 to 2017, including Deputy Commissioner for Global Regulatory Operations and Policy; Director of the Office of Compliance, Center for Drug Evaluation and Research; Deputy Associate Commissioner for Regulatory Affairs; and Director in the Office of Enforcement.

 

Sessions: 

Panel – FDA Inspectional Oversight Post-Pandemic: Challenges and Opportunities