Elizabeth Mulkey is an associate in Goodwin’s Technology and Life Sciences groups and a member of the firm’s FDA regulatory practice. She counsels pharmaceutical, biologic, medical device, digital health, and consumer product companies on FDA regulatory compliance issues, including advertising, promotion and labeling review, drafting and review of standard operating procedures, drug and device development issues, interactions with FDA, internal corporate investigations, and responding to FDA inspection observations and enforcement actions. Ms. Mulkey also advises FDA-regulated entities in corporate transactions, offerings, and licensing matters.

Areas of Practice
Domaines D’Expertise





  • Serves as legal reviewer on internal promotional review and medical legal regulatory (MLR) committees for pharmaceutical and medical device companies, providing legal assessment and analysis of publications, social media posts, medical affairs materials, sales training materials, commercial outreach plans, and print and digital launch and promotional materials.
  • Provides extensive review of corporate communications and regulatory disclosures in securities filings for pharmaceutical and medical device companies across the preclinical to commercial stages, including for corporate presentations, press releases, exhibit booth content, and communications with patient advocacy groups.
  • Counsels on company responses to FDA advisory and enforcement letters and responses to FDA Form 483 inspection observations.
  • Conducts regulatory due diligence reviews and provides corporate support for M&A transactions, private equity investments, individual investments and licensing deals involving FDA-regulated entities, including healthcare and digital health companies.
  • Advises on the regulatory classification of over-the-counter drug and medical device products and allowable marketing and labeling claims for such products.
  • Reviewed available literature to advise pharmaceutical and medical device companies on the utilization of additional claims and data by sales or medical affairs teams, including from real-world evidence studies.
  • Led in-house compliance training for a pharmaceutical client’s sales force.*

* Denotes experience prior to joining Goodwin.

Professional Activities

Ms. Mulkey is a member of the Food and Drug Law Institute (FDLI) and is a frequent speaker at FDLI training events for new FDA employees.


Ms. Mulkey has been recognized by The Best Lawyers in America Ones to Watch for her work in Technology Law 2022. 

Ms. Mulkey was named to the 2020 and 2021 Washington, D.C., Super Lawyers list of “Rising Stars” in Food & Drug Law, and The Best Lawyers in America 2021: Ones to Watch.

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J.D., 2015
Vanderbilt University Law School
B.A., 2012
University of Georgia
(magna cum laude)



District of Columbia
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Our clients rely on us for world-class advisory services, counsel on complex transactional work and high-stakes litigation. Specializing in matters involving the financial, life sciences, private equity, real estate, and technology industries, we use a collaborative, cross-disciplinary approach to resolve our clients’ most challenging issues. To find out more, please contact us.


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Unsere Kunden verlassen sich auf unsere erstklassige Beratung, vor allem im Hinblick auf komplexe Transaktionen und High-Stakes-Prozesse. Spezialisiert auf Angelegenheiten der Finanz-, Life-Sciences-, Private-Equity-, Immobilien-und Technologie-Branchen, verwenden wir einen kooperativen und interdisziplinären Ansatz, um Fragen unserer Kunden auch in extremen Spezialsituationen einer Lösung zuzuführen. Sie wollen mehr erfahren? Kontaktieren Sie uns gerne.

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