Monica Groat advises companies on regulatory, litigation, and transactional matters involving the Food and Drug Administration (FDA) and the life sciences industry.

Ms. Groat counsels pharmaceutical, biotechnology, medical device, tobacco, dietary supplement, food, and other related industry clients regarding all aspects of the FDA-regulated product life cycle, including:

  • Pre-market product development and clinical and pre-clinical testing
  • Product submissions
  • Compliance with good manufacturing and quality system regulations
  • Product marketing, promotion, and labeling
  • Regulatory inspections and product recalls

Ms. Groat draws on her science background and experience with all stages of life science product regulation and enforcement to help clients resolve litigation against the FDA and other federal agencies.

She also regularly advises on regulatory matters in connection with capital markets and M&A transactions involving FDA-regulated entities.

Before joining Latham, Ms. Groat was a trial attorney for the Consumer Protection Branch of the US Department of Justice’s Civil Division. Previously, she worked as a food, drug, and medical device enforcement associate at an international law firm.

During law school, Ms. Groat was a member of The University of Chicago Legal Forum.

She currently serves as a member of the Food and Drug Law Institute’s Webinar Committee.

Ms. Groat’s experience includes representing:

Regulatory and Transactional

  • A growth-stage medical device company in guidance relating to FDA submissions for two products, product promotions, and the development of a clinical program, as well as general corporate work
  • A wearable technology and digital health company in responding to an FDA warning letter
  • GRAIL, a healthcare company focused on multi-cancer early detection, on the FDA regulatory aspects of its acquisition by Illumina, a genetic sequencing company

Litigation

  • Genus Lifesciences in litigation regarding an FDA patent certification issue, in which the court granted partial summary judgment on Genus’ behalf
  • A tobacco company in litigation against the FDA regarding the wrapping warnings on cigarette packaging

Bar Qualification

  • District of Columbia
  • Virginia

Education

  • J.D., University of Chicago Law School, 2010
  • BA (Hons) in Biological Sciences & Religious Studies, University of Chicago, 2007

Languages Spoken

  • English