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what we do / Drug & Device Regulatory Issues

know the FDA from the inside out to speed products to market

Tucker Ellis lawyers work on the cutting edge of science and medicine with nationally recognized experts to defend litigation and resulting regulatory matters arising out of such litigation, including the development of appropriate warnings and the evaluation of pharmacovigilance practices. With our national reputation as lead and liaison defense counsel in multidistrict litigation and our deep experience as national coordinating counsel, regional counsel, and local counsel, we have the structure and team in place to help our clients navigate the often confusing world of regulatory compliance.

Our team has handled dozens of litigations against pharmaceutical and medical device manufacturers as national counsel. In defending our clients, we focus on the development and implementation of regulatory defense themes for trial, including fact witnesses and expert witnesses. We research and analyze the regulatory history through post-marketing phases, and address the impact of publicity generated by litigation, which can lead to increased regulatory oversight and resulting actions.

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areas of emphasis

  • Pharmaceutical and medical device product regulatory history
  • Development of regulatory trial themes and preparation of fact and expert witnesses
  • Life cycle management issues
  • Pharmaceutical and medical device monitoring, reporting, and recalls
  • Labeling compliance
  • Pharmacovigilance
  • HIPAA and privacy issues
  • Medicare reporting and compliance
  • Intellectual property and patent protection
  • Biologics
  • False Claims Act and anti-kickback laws
  • FDA and FTC enforcement actions and government challenges
  • Working knowledge of European and Canadian regulatory authorities
  • Preemption

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