Department profile
Morgan, Lewis & Bockius LLP

Healthcare: Pharmaceutical/Medical Products Regulatory

USA Guide 2026 : District of Columbia

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Morgan, Lewis & Bockius LLP

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About

Provided by Morgan, Lewis & Bockius LLP

Morgan Lewis provides sophisticated, integrated, and cost-effective counsel to businesses and organizations across the full spectrum of the healthcare industry. Our healthcare provider clients include hospitals and health systems; long-term care, home health, and hospice providers; retail and specialty pharmacies; behavioral health providers; suppliers; distributors; physician practices; medical societies; and private equity and venture capital investors, as well as the vendors that support these providers.

Our team includes some of the most respected healthcare law practitioners in the United States and a number of former senior US government officials. Leveraging our lawyers’ intimate knowledge of the inner workings of the government’s executive branch, and the regulatory agencies most critical to healthcare businesses, we bring special insight and savvy to the complex challenges and opportunities that our healthcare industry clients confront in the post–healthcare reform era.

Chambers Review

Provided by Chambers

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

Band 3

What the Team is Known For

Morgan, Lewis & Bockius demonstrates extensive capabilities in health law compliance matters, including investigations and other regulatory challenges. It attracts a broad roster of clients, including healthcare service providers, pharmaceutical and biotech companies. It frequently acts on civil and criminal litigation, as well as representing private equity firms in high-value healthcare acquisitions. The team offers notable expertise in advising on complex coverage and reimbursement issues, and is also noted for its FDA regulatory capabilities.

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Strengths

Provided by Chambers

  • They are detail-oriented, creative in their arguments and extremely well-versed.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

  • Morgan Lewis has a great reputation. The healthcare team is knowledgeable and responsive.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

  • They have unparalleled regulatory experience, not just on legal but also on compliance matters. They have the ability to advise not just on requirements but also to calibrate with company needs.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

  • They are responsive and creative in thinking through options.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

  • Morgan Lewis is incredibly responsive. The level of service is consistently excellent.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

Notable Practitioners

Provided by Chambers

  • Howard J Young
    Howard J Young

    Howard J Young

    Howard Young offers impressive skills in complex fraud and abuse mandates, as well as advising on compliance and data privacy issues.

    • Howard is simply exceptional. He is equally comfortable in lawyer-to-lawyer conversations as he is in lawyer-to-businessperson conversations. He has an uncanny ability to predict how issues are going to resolve at the inception of a matter.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

    • Howard is undoubtedly the best in the business when it comes to home health and hospice compliance and regulatory matters. He is always responsive and provides practical advice.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

    • Howard is always responsive and thoughtful in his analysis. He understands our business's risk tolerance and provides practical legal guidance.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

    • Howard is exceptional in every way.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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  • Kathleen M Sanzo
    Kathleen M Sanzo

    Kathleen M Sanzo

    Kathleen Sanzo focuses on pharmaceutical and medical products regulatory matters, including genetic testing and innovative drug research.

    • Kathleen has done an excellent job at supporting our team from a regulatory perspective. She understands our products and our business objectives very well.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

    • Kathleen has been a valued resource for my company regarding regulatory and compliance matters.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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  • Albert W Shay
    Albert W Shay

    Albert W Shay

    Albert Shay represents a range of healthcare clients, including prominent pharmaceutical companies, in complex FDA compliance matters, investigations and other regulatory issues.

    • Al is a tremendous resource.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

    • Al is incredibly practical.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

    • Al is a strategic thinker.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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  • Dennis Gucciardo
    Dennis Gucciardo

    Dennis Gucciardo

    Dennis Gucciardo offers extensive knowledge to a wide range of pharmaceutical and device manufacturers on FDA regulations and compliance. He provides counsel on such issues as licensing agreements.

    • Dennis provides excellent customer service. He's probably the most knowledgeable lawyer out there when it comes to tactical quality management system compliance issues.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

    • Dennis is absolutely incredible and a great adviser. He has massive medical device and dentistry experience and he has unique knowledge in regulatory matters.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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  • Michele Buenafe
    Michele Buenafe

    Michele Buenafe

    Michele Buenafe serves as the firm's digital health team leader and healthcare industry team co-leader. Clients turn to her for FDA regulatory compliance and enforcement issues. She is especially known for her expertise in digital health-related issues.

    • Michele quickly responds to requests.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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Ranked Individuals at Morgan, Lewis & Bockius LLP (5)

District of Columbia

Members

Provided by Morgan, Lewis & Bockius LLP

Morgan, Lewis & Bockius LLP has rankings in the following guides

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