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Jennifer Zachary
Jennifer Zachary
Washington +1 202 662 5037 Download V-card

Jennifer Zachary is a partner in the firm’s food and drug practice group.  She advises companies and industry associations on complying with FDA requirements for the manufacture and sale of drugs, biologics, medical devices, foods and dietary supplements and assists clients in responding to FDA enforcement actions, warning letters, inspections, recalls and import detentions.

  • Advise on issues relating to the labeling, marketing and promotion of FDA-regulated products.
  • Represent in connection with FDA-related investigations and seizure and injunction actions.
  • Draft responses to FDA Warning Letters and FDA-483 Inspectional Observations.
  • Assist with Hatch-Waxman issues regarding exclusivity, citizen petitions and litigation strategy.
  • Provide strategic advice regarding safety reporting requirements for marketed products.
  • Conduct regulatory due diligence evaluations for mergers and acquisitions.

Previous Experience

  • U.S. Food and Drug Administration, Associate Chief Counsel for Enforcement (2005-2011)
  • U.S. Attorney’s Office for the District of Columbia, Civil Division, Special Assistant U.S. Attorney (2009)
  • Chambers USA - America's Leading Business Lawyers, Healthcare: Pharmaceutical/Medical Products Regulatory (2014-2016)
  • Legal 500 US, Healthcare - Life Sciences (2016) 
  • Washington DC Super Lawyers, Food & Drugs "Rising Star" (2014)