Krista Hessler Carver is an associate in the firm’s Food and Drug Practice Group. She advises medical device, biotechnology, pharmaceutical and cosmetic manufacturers and trade associations on a wide range of FDA regulatory, compliance, transactional, and legislative matters. Ms. Carver has particular experience with legal and regulatory issues related to biosimilars, medical devices, combination products, and personalized medicine.
Ms. Carver writes and speaks regularly on subjects such as medical device regulation, biosimilars, and personalized medicine, and she is Co-Editor-in-Chief of Covington’s InsideMedicalDevices blog.
- Assisted biotechnology innovators in legislative matters leading up to enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Represent clients in connection with FDA interpretation and implementation of the BPCIA.
- 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. Conduct regulatory due diligence for device transactions.
- Representation of Genzyme Corporation in negotiation of 2010 consent decree regarding Allston Landing manufacturing facility.
- 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. Drafted comments on FDA draft companion diagnostic guidance on behalf of a major pharmaceutical company.
- Counsel clients on product jurisdictional issues, including distinctions between devices, drugs, cosmetics, and combination products. Assist clients in preparing requests for designation for novel products.
- Representation of major pharmaceutical company in Justice Department investigation concerning company’s interactions with physicians and investigators.
- Assisted nonprofit organization with federal legislative efforts related to pharmacy compounding.
Memberships and Affiliations
- Food & Drug Law Journal, Editorial Advisory Board, Member (2008-2013), Chair (April 2012-April 2013)
- ABA Science and Technology Law Section, Council Member and Chair, Biotechnology Law Committee
Publications and Speeches
- "FDA Regulation of the New Drug Development & Approval Process," Seton Hall Law Healthcare Compliance Certification Program (10/16/2013)
- "Key Regulatory Guidelines for the Development of Biologics in the United States and Europe," Biological Drug Products: Development and Strategies (Wei Wang & Manmohan Singh (eds.)), 75-109. (October 2013), Co-Author
- "Biosimilars and the BPCI Act: Where Are We Now and Where Are We Going?," CLE Webinar sponsored by the ABA Section of Science & Technology Law and ABA Section of Intellectual Property Law (9/19/2013)