Denise Esposito is the co-chair of Covington & Burling’s global Food, Drug, and Device Practice Group. Denise has more than 25 years of experience in the life sciences industry, including senior leadership roles within U.S. Food and Drug Administration (FDA), as the general counsel of a publicly traded biotechnology company, and as a partner in private practice. She provides strategic, policy, and regulatory advice to biotechnology, pharmaceutical, and medical device clients, with a focus on matters that involve navigation of FDA and the complex political and policy challenges that FDA-regulated companies are facing. Denise’s practice includes advising clients on marketing authorization strategies, expedited approval programs, life cycle management, and the promotion of medical products. She works with clients on FDA engagement strategies, formal and informal FDA dispute resolution, and crisis management around FDA actions.