Speaker details

Biography

Howard Sklamberg counsels clients on a wide range of compliance and enforcement issues related to US Food and Drug Administration (FDA) regulation and policy. His experience is rooted in a deep understanding of US and foreign food, drug and medical devices law and policy, and is able to guide domestic and international clients through the regulatory challenges they face. Areas of expertise include inspections and warning letters, investigations, civil and criminal enforcement, medical product applications and clinical research, food and hemp regulation, 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. While at the agency, he directed an office of over 5,000 employees in more than 200 offices, laboratories and import facilities across the United States, Asia, Europe, and Latin America. As Deputy Commissioner, Mr. Sklamberg was FDA's top enforcement official. He oversaw the agency's inspections, enforcement, recalls, and import operations programs.