Capabilities

Life Sciences and Healthcare Regulatory

Language

Our Life Sciences and Healthcare Regulatory practice has been recognized by virtually every leading legal publication as a leading practice in the field, including:

  • Chambers Global 2008-2020 for Life Sciences.
  • Chambers USA 2005-2019 for Life Sciences (Nationwide) and Healthcare: Pharmaceutical/Medical Products Regulatory (Nationwide).
  • Chambers UK 2013-2020 for Life Sciences; Life Sciences: Product Liability; and Life Sciences: Regulatory (Band 1).
  • Chambers Europe 2019 for Regulatory: Life Sciences/Pharma (Europe-wide).
  • LMG Life Sciences Guide 2012-2019 for Non-IP Litigation & Enforcement: White-Collar/Government Investigation.
  • LMG Life Sciences Guide 2017-2019 Life Cycle Firm.
  • The Legal 500 US 2013-2018 for Healthcare: Life Sciences.
  • The Legal 500 UK 2008-2020 for Pharmaceuticals and Biotechnology.
  • Law360 2016 Healthcare Practice of the Year.

Arnold & Porter's Life Sciences and Healthcare Regulatory practice is unique—unlike other firms, which typically scatter these capabilities across various siloed practices, we maintain a fully integrated team focused on providing comprehensive assistance to our clients in all areas of life sciences product and healthcare regulation. Our clients range from global enterprises to early-stage start-ups and include manufacturers of pharmaceutical, biotechnology, medical device and diagnostic products, healthcare professionals and other providers of health care services, universities, and some of the leading trade and professional organizations and societies. We also do extensive work for companies in the food, dietary supplement, over-the-counter (OTC) drug and cosmetic fields.

Our practice supports virtually every aspect of our clients' regulated business activities, including development of US FDA and EU 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. We cross-train all of our lawyers to recognize the complex array of issues that impact the business of our life science and healthcare professional and provider clients to ensure that our advice and assistance is practical and seamless.

Our team is comprised of an array of highly experienced lawyers and other professionals, many with senior government, in-house, and corporate professional experience, as well as attorneys who hold advanced degrees in diverse areas such as neurobiology, endocrinology, nursing, bioethics, biophysics, biochemistry, and biotechnology.

Perspectives

Update on Medical Products Shortage Reporting: What Manufacturers Need to Know Regarding FDA's New Reporting Guidance and Expanded Reporting Under the CARES Act
Coronavirus: Life Sciences and Healthcare Regulatory Advisory
The Over-the-Counter Monograph Safety, Innovation, and Reform Act Is Enacted: Top Five Takeaways for Manufacturers of OTC Drug Products
Advisory
COVID-19: Key Developments for FDA-Regulated Consumer Product Companies
Coronavirus: Multipractice Webinar
Telehealth During COVID-19: New Rules And Considerations
Commercial Contracts Law360, Compliance Law360, Consumer Protection Law360, Cybersecurity & Privacy Law360, Health Law360, Life Sciences Law360, Personal Injury & Medical Malpractice Law360, Public Policy Law360, Technology Law360, Telecommunications Law360
DEA Proposes Regulatory Changes to Facilitate Marijuana Production and Distribution for Research
Advisory
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Recognition

Chambers Global
Life Sciences (Global-wide) (2008-2020)
Life Sciences (Europe-wide) (2013-2020)
Life Sciences & Pharmaceutical Sector (International & Cross-Border) (United Kingdom) (2020)
Life Sciences & Pharmaceutical Sector (International & Cross-Border) (United States) (2020)
Chambers UK
Life Sciences (UK-wide) (2020)
Life Sciences: Product Liability (UK-wide) (2020)
Life Sciences: Regulatory (UK-wide) (2020)
The Legal 500 Asia-Pacific
Healthcare and Life Sciences: Foreign Firms (China) (2020)
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Overview

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