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

Krista Hessler Carver focuses on FDA regulatory and legislative matters for companies in the biotechnology, pharmaceutical, medical device, and cosmetic industries and related transactional matters. 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regarding the BPCIA and FDA implementation of the biosimilars pathway, including preparation of comments on FDA draft guidance and citizen petitions, drafting of requests for reference product exclusivity, and developing life cycle management strategies.
  • Advise clients on securing and transferring tropical disease and rare pediatric disease priority review vouchers and provide regulatory support for related transactions.
  • Develop citizen petitions for innovative companies regarding bioequivalence and other testing standards for generic drugs and related labeling requirements. For example, on behalf of Auxilium Pharmaceuticals, prepared successful citizen petition regarding necessary testing for generic versions of Testim.
  • Prepare submissions to FDA regarding regulatory classification of products, including requests for designation and section 513(g) request for information.
  • 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 product 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.

Memberships and Affiliations

  • Food & Drug Law Journal, Editorial Advisory Board, Member (2008-2013), Chair (April 2012-April 2013)
  • Food and Drug Law Institute, Drugs and Biologics Committee, Member    
  • ABA Science and Technology Law Section, Council Member and Former Chair, Biotechnology Law Committee
  • Washington DC Super Lawyers, Food and Drug "Rising Star" (2016)