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Mr. Gerald (Jerry) Masoudi has more than 25 years of broad experience in the life sciences industry. He served as Chief Counsel of the U.S. Food and Drug Administration (FDA) from 2007 to 2009. Mr. Masoudi also has held positions in the Antitrust Division at the US Department of Justice; as the general counsel of two large, highly regulated companies; and as a partner in private practice. He provides strategic legal, policy, and regulatory advice to life sciences clients, with a focus on FDA enforcement of manufacturing and promotional rules. His practice will focus on guiding clients through significant corporate transactions, litigation, shifting regulatory expectations, and intensive crisis management activities.

  • Conducted internal investigations of medical products manufacturers relating to alleged misconduct in product development and manufacturing.
  • Advised companies responding to FDA inspection reports (483s) and warning letters relating to manufacturing, labeling and promotion.
  • Advised numerous medical products manufacturers on potential recalls relating to quality issues.
  • Lead counsel for Genzyme corporation in negotiation of 2010 consent decree regarding Allston Landing manufacturing facility.
  • Lead counsel for major drug manufacturer in negotiation of 2011 consent decree regarding OTC manufacturing facilities.
  • Regulatory advisor for defense of off-label/False Claims Act investigations for major pharmaceutical companies.
  • Advised major OTC drug manufacturer on labeling and formulation requirements for wide range of OTC drugs.
  • Chambers Most Influential GCs – USA Band 1 (2020)
  • Chambers USA - America's Leading Business Lawyers, Healthcare: Pharmaceutical/Medical Products Regulatory (2012-2014)
  • Legal 500 US, Healthcare: Life Sciences (2013-2014)
  • Best Lawyers in America (2012-2014)
  • LMG Life Sciences Awards, shortlisted for FDA Pharmaceutical Attorney of the Year (2013)
  • LMG Life Sciences, “Life Science Star” (2012-2013)
  • Washingtonian Magazine, Washington's Best Lawyers (2011, 2013)
  • The Practical Law Company (PLC) - Life Sciences, Which Lawyer? (2011-2012)