Stacy Cline Amin

Practice Areas

FDA Regulatory + Life Sciences Compliance

Career

Stacy Cline Amin leads the FDA Regulatory & Compliance practice and provides strategic regulatory and business advice to companies in the life sciences, healthcare, and technology industries. Stacy previously served as Chief Counsel of the U.S. Food and Drug Administration (FDA) and held senior positions within the White House Counsel’s Office and health committees in both the House and Senate. With her depth of experience across government agencies, she provides an insider’s perspective on regulatory and compliance issues, enforcement actions, and litigation challenges.

During her tenure, she served as a trusted strategist and advisor to several FDA Commissioners, helping to resolve challenging legal and regulatory issues, including in the areas of human gene therapy and regenerative medicine, in vitro diagnostics, medical device safety and innovation, digital health, animal and plant biotech, food safety, compounding, opioids, and e-cigarettes. She also oversaw the agency’s significant civil and criminal enforcement actions, in coordination with the Department of Justice, and advised on all of the agency’s novel or significant compliance activities. Most notably, she served as a key leader of the team responsible for issuing the first two COVID-19 vaccine authorizations.

Personal

Harvard Law School, J.D., 2004