Howard Sklamberg

Howard Sklamberg counsels clients on a wide range of compliance and enforcement issues related to U.S. Food and Drug Administration (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, and is able to guide domestic and international clients through the regulatory challenges they face. Areas of focus include inspections and warning letters, investigations, civil and criminal enforcement and litigation, 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. Howard is also a litigator and represents FDA-regulated companies and individuals in criminal and civil investigations, discovery, and trial.