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Companies regulated by the FDA face continuous government scrutiny and encounter a range of legal, regulatory and business challenges, whether they are just starting out or have been in operation for decades.

  • Advised pharmaceutical companies in assessment of and response to safety signals of potentially life threatening conditions.
  • Represented a compounding pharmacy during a recall of compounded medications following a FDA and State Board of Pharmacy inspection.
  • Represented a medical device company on product safety positions taken by the Centers for Disease Control and Prevention and healthcare epidemiology societies.
  • Represented a pharmacy during an FDA inspection of the pharmacy’s compounding area and activities.
  • Advised pharmaceutical, medical device and cosmetic companies on advertising claims that required the assessment of clinical trials.
  • Advised private equity funds during the diligence of both FDA manufacturers and licensed pharmacies.
  • Helped academic medical centers to develop policies and procedures for managing conflicts of interest and apply them in specific research projects.
  • Represented pharmacies and wholesale distributors in front of 50 state boards of pharmacy.
  • Defended pharmaceutical companies in nationwide products liability litigation arising from analgesic, cough-cold and colonoscopy preparation products.

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