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.