Krista Hessler Carver

Krista Hessler Carver

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Krista Carver is a partner in the firm of Covington & Burling LLP. She focuses on FDA regulatory and legislative matters for companies in the biotechnology and pharmaceutical industries and related transactional matters. Ms Carver counsels clients on an array of matters, including biosimilars and Hatch-Waxman regulatory issues; regulatory exclusivities and life cycle management strategies; priority review vouchers; risk evaluation and mitigation strategies (REMS); FDA’s expedited programmes; and clinical trial data confidentiality and transparency. Ms Carver also assists clients with advocacy before FDA, including formal dispute resolution requests and citizen petitions, and with legislative issues surrounding amendments to the Federal Food, Drug, and Cosmetic Act and related laws, including the recently passed 21st Century Cures Act and FDA Reauthorization Act of 2017. With respect to biosimilars, she assisted biotechnology innovators in legislative matters leading up to enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and now represents clients in connection with FDA interpretation and implementation of the BPCIA. She received her law degree, magna cum laude, from Harvard Law School in 2006.

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