Krista Carver is a co-chair of Covington’s Life Sciences – Pharmaceutical and Biotechnology Industry Group. She counsels clients on an array of issues, including biosimilars, orphan drug, and Hatch-Waxman regulatory issues; digital health; gene therapies; pediatric testing; regulatory exclusivities and life cycle management strategies; priority review vouchers; risk evaluation and mitigation strategies (REMS); FDA’s expedited programs; regulation of human cellular, tissue, and cellular and tissue-based products (HCT/Ps); and proprietary naming of pharmaceuticals. 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 21st Century Cures Act, FDA Reauthorization Act of 2017, and the SUPPORT for Patients and Communities Act.
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).
Harvard Law School, J.D., 2006