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Krista Carver
Krista Hessler Carver
Washington +1 202 662 5197 Download V-card

Krista Hessler Carver has a wide-ranging practice that includes FDA regulatory, transactional, and legislative matters for companies in the biotechnology, pharmaceutical, medical device, and cosmetic industries. She has particular experience with biosimilars issues. 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.

  • Outside counsel to PhRMA on FDA regulatory aspects of 21st Century Cures Act. Advises PhRMA on a range of regulatory and legislative matters including with respect to biosimilars, REMS, and Hatch-Waxman issues.
  • Represent numerous biotechnology innovators regarding the BPCIA and FDA implementation of the biosimilars pathway.
  • Provided strategic regulatory law support to appellate litigation team in preparing amicus brief on behalf of the Pharmaceutical Research and Manufacturers of America in Takeda Pharmaceuticals, U.S.A., Inc. v. Burwell, No. 15-5021 (D.C. Cir. 2015), an appeal concerning the proper interpretation of section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
  • On behalf of Auxilium Pharmaceuticals, prepared successful citizen petition regarding necessary testing for generic versions of Testim.
  • Advise clients regarding regulatory and legislative developments on personalized medicine and related life cycle management and legislative strategies for biologics, drugs, and diagnostics.
  • Advise clients on all stages of medical device development and marketing, including pathways to market, clinical trial regulation, premarket submissions, FDA clearance or approval, advertising and promotion, postmarket reporting obligations, and recalls.
  • Representation of Genzyme Corporation in negotiation of 2010 consent decree regarding Allston Landing manufacturing facility.
  • Washington DC Super Lawyers, Food and Drug "Rising Star" (2016)