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Maria Kalousi-Tatum

Associate

Maria Kalousi-Tatum advises clients on US Food and Drug Administration (FDA) approval, compliance, enforcement, and promotion matters related to medical devices and digital health technologies, including software as a medical device (SaMD), clinical decision support software, wearable devices, artificial intelligence systems, and mobile medical apps. She also counsels on US Drug Enforcement Administration (DEA) and state regulatory issues for controlled substances and medical products. Maria advises clients on FDA, Federal Trade Commission (FTC), and National Advertising Division (NAD) compliance and enforcement matters—as well as false advertising class action litigation—related to food and dietary supplements.

Extended Profile

Prior to joining Morgan Lewis, Maria served as a clerk to Judge Nancy B. Firestone of the US Court of Federal Claims and the Office of Special Masters, where she worked on vaccine-related litigation. Maria previously interned at the Center for Science in the Public Interest and worked as translator for the European Commission and for multinational pharmaceutical and medical device companies. She speaks fluent French, Greek, and Spanish and has professional working proficiency in Catalan and Portuguese.

Education

  • Georgetown University Law Center, 2018, LL.M., Environmental & Energy Law, with Distinction, Dean’s List
  • Tulane University Law School, 2017, J.D.
  • Heriot-Watt University, Scotland, 2008, M.S., Translation & Conference Interpreting, with Overall Distinction
  • University of Glasgow, Scotland, 2006, M.A. (Hons), French & Hispanic Studies, Upper Second Class, Distinction in Spoken Spanish

Admissions

  • District of Columbia
  • New York

Clerkships

  • Clerkship to Office of Special Masters of the US Court of Federal Claims (2018 - 2019)
  • Clerkship to Judge Nancy B. Firestone of the US Court of Federal Claims (2017 - 2018)

Awards and Affiliations

Member, Food & Drug Law Institute New to Food and Drug Law Planning Committee (2021)

Recipient, Thomas Bradbury Chetwood, S.J. Prize for the Most Distinguished Academic Record, Georgetown University Law Center

Publications

News

Events