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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.

  • 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.

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)