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FDA + Healthcare Regulatory and Compliance

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Our FDA attorneys advise clients in the life sciences and healthcare industries, helping them navigate complex regulatory, compliance issues and more.

Case Studies

LSX World Congress USA

MoFo Presents on Important Regulatory, Enforcement, and Litigation Developments Affecting Life Sciences Companies for GSK

Future4Care Institut - In Silico Modeling in Healthcare Conference

2023 FCBA Bench & Bar Conference

ACI’s 11th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements

NFLR Summer Series: The Intersection Between FDA and Other Government Agencies

Events

Medicare Drug Price Negotiation Program Final Guidance

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways

FDA on Use of AI/ML in Drug Development: Five Key Takeaways

FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims

Insights

Morrison Foerster Recognized as a Leading Life Sciences Practice by LMG Life Sciences

Eleven from MoFo Named to Law360 Editorial Advisory Boards

Stacy Cline Amin Named Regulatory Attorney of the Year: FDA Pharmaceutical by LMG Life Sciences

Attorney Says PCCPs With Change in Indication for Use Not Completely Impracticable

Melissa Crespo Selected as a 2023 MCCA Rising Star

Draft Cell and Gene Therapy Guidance Document Calls for Comparability and Lifecycle Management

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Stacy Cline Amin leads the FDA + Healthcare Regulatory and Compliance practice within the firm’s Global Life Sciences + Healthcare Group 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 Deputy General Counsel of the Department of Health and Human Services (HHS), 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 clients with an insider’s perspective on regulatory and compliance issues, enforcement actions, and litigation challenges.As chief counsel of the FDA, Stacy led an office of approximately 170 counselors and litigators and navigated difficult regulatory issues and litigation challenges across the agency’s entire portfolio. During her last year of service, Stacy played a critical role in nearly every aspect of FDA’s COVID-19 pandemic response effort, including record numbers of emergency use authorizations, guidances, and compliance actions. Most notably, she served as a key leader of the team responsible for issuing the first two COVID-19 vaccine authorizations.During her tenure, she served as a trusted strategist and advisor to several FDA Commissioners, including former Commissioner Scott Gottlieb, the FDA Center Directors and Deputy Commissioners, and the HHS Secretary. She worked closely with the leadership of the agency 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 advised on legal issues related to all aspects of the medical product life cycle and worked with Center leadership to resolve novel or challenging issues that arose during product review. 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.For more than a decade, Stacy’s work has often focused on the intersection of health, life sciences, and technology. At FDA, she advised on the creation and launch of the Digital Health Center of Excellence and oversaw the development of regulations and policy in all areas of digital health, including software as a medical device, artificial intelligence and machine learning, medical device interoperability, and cybersecurity. While serving in Congress, Stacy led multiple bipartisan investigations of digital health, health IT, and cybersecurity issues that resulted in an influential oversight report, a series of six bipartisan hearings, and significant provisions of the 21st Century Cures Act of 2016 and the Cybersecurity Act of 2015.Previously, Stacy served in the White House Counsel’s Office as Senior Associate Counsel to the President, where she advised on matters involving the FDA and Centers for Medicare and Medicaid Services, the Federal Trade Commission, and the Federal Communications Commission.Prior to joining the White House, Stacy served as the Chief Counsel of the Senate Health, Education, Labor and Pensions Committee and as a Counsel for the House Energy & Commerce Committee. She frequently advised on FDA, insurance market, and health IT matters and led significant oversight investigations. These efforts supported a number of legislative accomplishments, including passage of the Drug Quality and Security Act of 2013.Earlier in her career, Ms. Amin served as an associate at two leading Washington, D.C. law firms, where she advised multinational financial services industry clients and startup organizations.She graduated cum laude from Harvard Law School and summa cum laude from the George Washington University in philosophy and clerked for the Hon. John R. Gibson on the U.S. Court of Appeals for the Eighth Circuit.

Stacy Cline Amin

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Toward a Therapy for COVID-19: The Science and Legal Considerations

Toward a Vaccine for COVID-19: The Science and Legal Considerations

Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations

FDA + Healthcare Regulatory and Compliance

Shortlisted for FDA Litigation & Enforcement Firm of the Year

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