Krista Hessler Carver
Global Guide 2024
Band 3 : Life Sciences: Regulatory/Compliance
Email address
[email protected]Contact number
202 662 5197Share profile
Band 3
About
Provided by Krista Hessler Carver
Practice Areas
Krista Carver is a co-chair of Covington’s Life Sciences – Pharmaceutical and Biotechnology Industry Group. Drawing on her nearly 15 years of experience, she provides strategic and practical advice to clients on an array of FDA regulatory issues. Her areas of focus include biosimilars, orphan drug, and Hatch-Waxman regulatory issues; digital health; gene therapies; pediatric testing; regulatory exclusivities and life cycle management strategies; risk evaluation and mitigation strategies (REMS); pharmacovigilance; and issues regarding medical products for COVID-19, including emergency use authorizations. Ms. Carver also assists clients with advocacy before FDA, including formal dispute resolution requests and citizen petitions. She also maintains an active policy practice, addressing legislative issues surrounding amendments to the Federal Food, Drug, and Cosmetic Act and related laws.
Publications
Ms. Carver writes and speaks regularly on subjects such as biosimilars and life sciences legislation. She co-authored a comprehensive article on the BPCIA, “An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009” (Food and Drug Law Journal, 2010) and the United States Chapter in the Life Sciences Law Review.
Personal
Harvard Law School, J.D., 2006; B.S., Chemistry, William & Mary, 2003.
Chambers Review
Global
Krista Hessler Carver counsels pharmaceutical and biotechnology businesses on legislative and regulatory developments and procedure, including Hatch-Waxman compliance, life cycle management, digital health and orphan drugs.
Strengths
Provided by Chambers
"Krista is very experienced and knowledgeable. She is able to take a complex set of issues and translates them into understandable English."
"Her analysis is very clear and she is a wicked smart lawyer."
"Krista is very experienced and knowledgeable. She is able to take a complex set of issues and translates them into understandable English."
"Her analysis is very clear and she is a wicked smart lawyer."
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