Amy has been representing FDA-regulated clients for more than 22 years. She works with a range of clients, including large and small companies, pharmaceuticals, devices, biotech, diagnostics, and research institutions, providing advice on clinical research, FDA interactions, and FDA-regulated products. She also helps clients navigate related CMS issues, including CMS reimbursement of clinical research and compliance with CMS requirements, such as Section 111 obligations for clinical trial sponsors and Open Payments (Sunshine) reporting.
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.
- Indiana University Robert H. McKinney School of Law — Adjunct Faculty