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Life Sciences & Healthcare Regulatory

Arnold & Porter's renowned Life Sciences and Healthcare Regulatory practice is unique in providing a fully integrated team focused on delivering comprehensive and sophisticated assistance to clients in all areas of life sciences product and healthcare regulation. Our clients include manufacturers of pharmaceutical, biotechnology, medical device, and diagnostic products; healthcare professionals; universities; and leading trade and professional organizations. We also represent companies in the food, dietary supplement, over-the-counter drug, and cosmetic fields. Our practice supports virtually every aspect of our clients' regulated business activities, including U.S. FDA, EU, UK, and China regulatory strategies; clinical trials; inspections; promotion and advertising; exclusivities; fraud and abuse; pricing; contracting; coverage and reimbursement; domestic and global compliance programs; government investigations; transactional diligence and post-transaction integration; and public policy advocacy.

  • Decades of Experience: Our global team has handled the most challenging life sciences and healthcare regulatory matters, from high-profile global regulatory investigations to unprecedented strategies for obtaining approval.

  • Deep Knowledge of Government and Science: Our highly experienced lawyers and other professionals are thought leaders in the field; many have senior government, in-house, and corporate professional experience, as well as advanced degrees in diverse scientific and medical fields.

  • Global in Scope: Our practitioners in the U.S., Europe, the UK, and Asia routinely handle global regulatory challenges for our clients, from compliance program development to simultaneous regulatory inspections.

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News & Perspectives

Media Mention

“Exciting New World”: Mahnu Davar Shares Insights on Decentralized Clinical Trials in Law360
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News

The Legal 500 UK 2025 Recognizes 15 Arnold & Porter Practices, 13 Lawyers
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Media Mention

What Comes Next for the BIOSECURE Act? Dan Kracov Shares Insights on Fierce Pharma’s “The Top Line” Podcast
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Media Mention

Threats From AI Regulators Are “Tangible,” Alexander Roussanov Tells Compliance Week
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Blog

EMA Adopts Reflection Paper on the Use of Artificial Intelligence (AI)
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Blog

A New 2024 Code for the British Pharmaceutical Industry – “The Future is Orange”
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Advisory

September 2024 Medicaid Rebate Final Rule: Key Issues for Manufacturers
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Further Reading

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Language - English

Focus Areas

Key Contacts

Allison W. Shuren
Allison W. Shuren
Partner
Washington, D.C.
+1 202.942.6525
Mahnu V. Davar
Mahnu V. Davar
Partner
Washington, D.C.
+1 202.942.6172
See All Related Professionals

Related Services

Recognition

  • Chambers UK
    Life Sciences – UK-wide: Band 1 (2024)
    Life Sciences: Product Liability – UK-wide: Band 1 (2024)
    Life Sciences: Regulatory – UK-wide: Band 1 (2024)
  • The Legal 500 US
    Healthcare: Life Sciences (2024)
    Healthcare: Service Providers (2024)
  • Chambers Europe
    Life Sciences – Europe-wide (2024)
    Life Sciences/European Law – Belgium (2024)
    Life Sciences – Netherlands (2024)
  • Chambers Global
    Life Sciences – Global-wide (2024)
    Life Sciences – Europe-wide (2024)
    Life Sciences and Pharmaceutical Sector: International and Cross-Border – UK (2024)
    Life Sciences and Pharmaceutical Sector: International and Cross-Border – USA (2024)
    Life Sciences: Regulatory/Compliance – USA (2024)
  • Chambers Greater China Region
    Life Sciences: International Firms – China (2023)
  • The Legal 500 Asia-Pacific
    Life Sciences and Healthcare: Foreign Firms – China (2023)
  • Law360
    "Practice Group of the Year" (2022)
  • LMG Life Sciences Guide
    Regulatory Healthcare: Pricing and Reimbursement (2022)
    Regulatory FDA: Pharmaceutical (2022)
    Regulatory FDA: Medical Devices (2022)
  • The Legal 500 UK
    Industry Focus: Life Sciences and Healthcare (2023)
  • Chambers USA
    Healthcare: Highly Regarded – Nationwide (2024)
    Healthcare: Pharmaceutical/Medical Products Regulatory – Washington, D.C. (2022-2024)
    Healthcare – Washington, D.C. (2022-2024)
    Life Sciences – Nationwide, California (2022-2024)
    Life Sciences: Regulatory/Compliance (Nationwide) (2022-2024)
  • Above the Law
    "Outside Counsel Rankings" Top counsel in Healthcare/Life Sciences (2021)
  • Managing Intellectual Property
    "U.S. Firm of the Year" Life Sciences IP Litigation (2021)
  • Chambers Asia-Pacific
    Life Sciences (International Firms) (2021)
  • U.S. News & World Report and Best Lawyers
    "Best Law Firms" FDA Law – Washington, D.C., National (2024)
    "Best Law Firms" Healthcare Law – Washington, D.C., National (2024)
  • LMG Life Sciences Awards
    Life Cycle Firm of the Year - United States (2022-2023)
    Regulatory Firm of the Year (2023)