Elizabeth Mulkey

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. Elizabeth also advises FDA-regulated entities in corporate transactions, offerings, and licensing matters.

• 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.

Elizabeth is a member of the Food and Drug Law Institute (FDLI) 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 for her work in Technology Law 2022.

Elizabeth 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.

• Contributor, "Guide to Biosimilars Litigation and Regulation in the U.S., 2022-2023 ed.," published by Thomson Reuters, December 2022
• 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