Elizabeth Mulkey

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

• Counsels 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 internal investigations on regulatory compliance matters, such as compliance with good clinical practices, product promotion, and drug sampling
• 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

Elizabeth is a member of the Food and Drug Law Institute (FDLI), a member of the FDLI Austern Writing Awards Committee, and is a frequent speaker at FDLI training events for new FDA employees.

Elizabeth has been recognized by The Best Lawyers in America: Ones to Watch since 2021, including for her work in Technology Law, Health Care Law, and Administrative / Regulatory Law.

Elizabeth was also named to the 2020, 2021, and 2022 Washington, D.C., Super Lawyers list of “Rising Stars” in Food & Drug Law.

• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2023-2024 ed.,” published by Thomson Reuters, January 2024
• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2022-2023 ed.,” published by Thomson Reuters, December 2022
• Speaker, “The New Faces of Campaigns: Regulatory Challenges in Influencer, Patient Ambassador, and Peer-Mentor Brand Advertising,” FDLI Advertising & Promotion for Medical Products Conference, October 2022
• Panelist, “ Strategies for Dealing with Payor Materials,” FiercePharma Promotional Review Committee Compliance & Best Practices Conference, September 2021
• Speaker, “Introduction to Drug Law and Regulation,” FDLI Virtual Training Course, November 2021 and April 2021
• Special Contributor, "Guide to Biosimilars Litigation and Regulation in the U.S., 2020-2021 ed.," published by Thomson Reuters, January 2021
• Co-Author, “U.S. CARES Act Supply Shortage: What Drug and Device Manufacturers Need to Know,” Goodwin Alert, April 2020
• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2019-2020 ed.,” published by Thomson Reuters, November 2019