LAWYER PROFILE

Covington & Burling LLP

Denise Esposito

Washington, DC, USA Global Guide 2021 Ranked in 1 departments
Ranked in : Life Sciences: Regulatory/Compliance
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Global
Life Sciences: Regulatory/Compliance - USA

Band 2

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Denise Esposito draws on substantial government and in-house experience to advice life sciences businesses on matters of strategy, policy and regulatory compliance. She advises biotech, pharmaceutical and medical devices companies of all sizes, from startups to major corporations.
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Denise Esposito co-chairs Covington’s Food, Drug, and Device Practice. She provides strategic, policy, and regulatory advice to life sciences clients, with a focus on matters that involve navigation of FDA and the complex political and policy challenges faced by FDA-regulated companies. Her practice includes advising clients on marketing authorization strategies, expedited programs, life cycle management, and the promotion of medical products. She counsels clients on FDA engagement strategies, dispute resolution, and crisis management around FDA actions, across a range of therapeutic areas and product types, including infectious disease, oncology, and medical countermeasures (MCMs) against emerging infectious diseases. She was part of the FDA's Medical Countermeasures Initiative MCMi team while at the Agency and has been heavily involved in the industry’s response to the Coronavirus Disease 2019 (COVID-19) pandemic.

Ms. Esposito has almost 30 years of experience representing life sciences clients. Prior to joining Covington, she served as Chief of Staff to the FDA Commissioner, Deputy Chief Counsel for Drugs and Biologics in FDA’s Office of Chief Counsel, and acting director of policy for FDA’s Center for Drug Evaluation and Research (CDER). Prior to joining FDA, Ms. Esposito was the general counsel of Emergent BioSolutions and previously a partner at WilmerHale.

Global

This individual is also ranked in:

USA 2021
Denise Esposito

Covington & Burling LLP

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One CityCenter, 850 Tenth Street

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Washington, DC

District of Columbia

USA

20001-4956

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