Karen C. Corallo is the former Director of the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Division of Drug Imports, Exports, Recalls, and Shortages. In this role, Karen authored and executed the Agency’s global drug imports strategy, managed operations and supervised staff, and spearheaded important drug policy initiatives for the Agency. Before that, Karen was Associate Chief Counsel in FDA’s Office of Chief Counsel, where she worked with the Department of Justice Consumer Protection Branch on enforcement matters involving all FDA-regulated commodities and with U.S. Attorneys’ Offices across the country on criminal enforcement matters. In addition to her government work, Karen was a commercial litigation partner for a global law firm and also served as in-house counsel at a Fortune 100 company.
Karen represents pharmaceutical, medical device, and food industry clients, advising them in litigation and providing counsel to businesses on administrative, regulatory, and enforcement matters.
- Health law
- Administrative law and agency practice
- Regulatory investigations