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Kristie Gurley advises pharmaceutical, biotechnology, medical device, food, dietary supplement, and cosmetic clients on a variety of issues before FDA and other regulatory agencies. Ms. Gurley regularly assists with evaluating policy opportunities, preparing public comments, and drafting proposed legislation for FDA-regulated industries. She also provides advice on regulatory risk associated with acquisitions and mergers of biotechnology companies, in addition to conducting regulatory due diligence to support corporate transactions and securities filings.

  • Advising clients on legislative developments and compliance implications for new legislation.
  • Preparing public comments and various submissions to FDA regarding pharmaceutical company communications, expedited programs, pediatric exclusivity, and other issues.
  • Advising pharmaceutical companies on regulatory strategy for clinical stage development and regulatory approval.
  • Analyzing state and federal regulatory compliance issues with respect to manufacturing, distribution, and other requirements.
  • Conducting internal investigations and assessing regulatory noncompliance, including with respect to claim substantiation for food, dietary supplement, and cosmetic companies.
  • Conducting regulatory due diligence for mergers, acquisitions, and public offerings.

Pro Bono

  • Represents low income tenants in eviction proceedings before the DC Landlord and Tenant Branch.
  • Represents non-profit organization in various state and federal lobbying efforts.
  • Provided regulatory advice to non-profit organization for its sponsorship of Summer Food Service Programs across the United States.