Amy Judge-Prein leads the firm's FDA-regulated products practice. She provides regulatory and strategic counsel to companies involved in the development of pharmaceuticals, medical devices, and diagnostics. Amy recognizes the operational and financial considerations involved in creating and managing compliance and regulatory strategies and works seamlessly with clients to achieve their research and product-development goals.
Amy has been representing FDA-regulated clients for more than 24 years. She works with a range of clients, including large and small companies, pharmaceuticals, HCT/Ps, devices, biotech, diagnostics, and research institutions, providing advice on clinical research, FDA interactions, and FDA-regulated products.
In-House Counsel Experience
Before joining Faegre Drinker, Amy practiced in-house for 11 years, where she served as lead legal counsel for the development and marketing of portfolios of products, including negotiating label and advertising issues with global regulators and competitors. Amy’s in-house responsibilities also included serving as lead legal counsel for many types of clinical trials, spanning thousands of patients, dozens of countries, and partnerships with government and academic institutions.
