SCOTT KAPLAN helps pharmaceutical, biotechnology, and medical device clients achieve and maintain compliance with complex Food and Drug Administration (FDA) requirements. Drawing on his deep understanding of the FDA's civil and criminal enforcement, Scott prepares clients for FDA inspections and works with them to respond to FDA 483s, Warning Letters, import alerts, investigations by the Office of Criminal Investigations, and other FDA enforcement actions.
Scott provides experienced counsel on Current Good Manufacturing Practice requirements, Quality System regulation, data integrity issues, product labeling, and Drug Supply Chain Security Act implementation, among others.
Scott previously served as Associate Chief Counsel for Enforcement in the FDA's Office of the Chief Counsel. At the FDA, Scott helped the agency resolve seizures, injunctions, administrative detentions, and criminal prosecutions, in addition to serving as a Special Assistant U.S. Attorney. Scott also acted as counsel for compliance matters to the FDA's district offices. Prior to his tenure at the FDA, Scott clerked for the Hon. Helene N. White of the U.S. Court of Appeals for the Sixth Circuit. Before joining Sidley, Scott was a partner at another global law firm.