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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.

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On January 19, 2018, FDA announced the availability of a new draft guidance, titled “Material Threat Medical Countermeasure Priority Review Vouchers.” FDA’s publication of the draft guidance, which was issued by FDA’s Office of Counterterrorism and Emerging Threats (OCET) without a statutory mandate – reflects the commitment of FDA leadership to the development and approval of medical countermeasures (MCMs). In a question and answer format, FDA provides details about the Agency’s interpretation and implementation of the MCM priority review voucher (PRV) program, which was established in December 2016 by the 21st Century Cures Act (Section 565A of the Federal Food Drug, and Cosmetic Act (FD&C Act)). That provision, intended to incentivize the development of MCMs, requires FDA to award a PRV to the sponsor of a successful marketing application that meets certain statutory criteria.

Continue Reading FDA Commitment to MCM Development Reflected in New Draft Guidance on Medical Countermeasure Priority Review Vouchers