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    Global Problem Solving from Covington: Deal with Complex Problems Anywhere in the World

    • Apr 08, 2021

Christina Kuhn

Associate

Washington +1 202 662 5653

  • About
  • Representative Matters
  • Credentials
  • About

    Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.

    Christina frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions. She also has significant experience counseling medical device companies on postmarket compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, and recalls. She advises clients on responding to and resolving enforcement actions, such as FDA inspections and Warning Letters as well as Department of Justice investigations.

    Christina advises clients on, and performs regulatory due diligence for, corporate transactions, including acquisitions, public offerings, co-development agreements, and clinical trial agreements.

    Christina also regularly assists industry associations and medical device and pharmaceutical companies in commenting on FDA guidance documents and rulemaking as well as drafting and analyzing federal legislation.

    Christina is a frequent contributor to Covington’s Digital Health and InsideMedicalDevices blogs.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Advise multinational software company on FDA regulatory status of digital health products.
    • Assist early-stage companies and multinational device manufacturers in preparing Pre-Submissions to FDA and obtaining FDA concurrence on regulatory pathway and clinical development programs.
    • Outside counsel to PhRMA on FDA regulatory aspects of 21st Century Cures Act.
    • Represent of major pharmaceutical companies in government investigations.

    • Represent of a leading biotechnology firm in FDA proceedings relating to withdrawal of approval for a product.
    • Develop citizen petitions for innovative companies regarding bioequivalence and other testing standards for generic drugs and related labeling requirements.

    Areas of Expertise

  • Credentials
    Education
    • New York University School of Law, J.D., 2010
        • Robert McKay Scholar
        • Annual Survey of American Law, Executive Articles Editor
    • Princeton University, B.S.E., 2005
        • Chemical Engineering
        • Sigma Xi
    Bar Admissions
    • District of Columbia
    • New York
    Pro Bono
    • Submitted amicus brief on behalf of medical professional and public health organizations supporting the availability of aid in dying in litigation in the New Mexico Supreme Court and the Court of Appeals for the State of New York.
    • Assisted reproductive rights non-profit analyze impact of bills creating the Women’s Health Protection Act on state laws.
    • Incorporation of a tenants association and representation of the association under the D.C. Tenant Opportunity to Purchase Act.
    • Favorable settlement for a non-profit mental health services agency in response to a race discrimination claim by a terminated employee filed with the District of Columbia Office of Human Rights.
    Memberships and Affiliations
    • New York State Bar Association
    Previous Experience
    • United States Attorney’s Office for the Southern District of New York, Civil Division, Intern (2010)
    • New York County District Attorney’s Office, Paralegal (2005-2006)

    Areas of Expertise

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