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Kristie Gurley advises pharmaceutical and biotechnology companies on marketing authorization and market access issues, including with respect to product development, product approval and launch, pricing and reimbursement activities, advertising and promotion, payer communications, value-based contracting, and related areas. Ms. Gurley routinely advises on regulatory compliance and enforcement risk, commercial transactions, and administrative and legislative policy opportunities.

  • Advising clients on public policy developments and compliance implications for new legislation or regulations, particularly with respect to recent drug pricing initiatives.
  • Preparing public comments and various submissions to FDA, CMS, and other agencies.
  • Advising pharmaceutical companies on regulatory strategies for product development, approval, and market access.
  • Analyzing state and federal regulatory compliance obligations related to contracting, pricing, manufacturing, distribution, prescribing, and dispensing medical products.
  • Providing strategic regulatory advice in False Claims Act cases and other litigation.
  • Conducting regulatory due diligence for mergers, acquisitions, and public offerings.

Pro Bono

  • Represents non-profit organizations in various state and federal policy efforts related to research and development, patient access, and healthcare issues.
  • Represents low income tenants in eviction proceedings before the DC Landlord and Tenant Branch.
  • Provided regulatory advice to non-profit organization for its sponsorship of Summer Food Service Programs across the United States.