Department profile
Arnold & Porter

Healthcare: Pharmaceutical/Medical Products Regulatory

USA Guide 2026 : District of Columbia

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Arnold & Porter

Rankings

Chambers Review

Provided by Chambers

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

Band 1

What the Team is Known For

Arnold & Porter is an impressive team with wide-ranging expertise in healthcare, pharmaceutical and medical device matters, including innovative technology and compliance issues. Integrated life sciences practice offers strong IT services to clients, alongside FDA and healthcare regulatory compliance counseling. Notable litigation capabilities include both civil and criminal defense work. Offers strength acting for organizational as well as individual clients in the healthcare space.

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Work Highlights

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  • Arnold & Porter advised Pfizer with respect to its agreement with the US government relating to pricing for Medicaid and newly launched medicines in the US.

Strengths

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  • They have a broad and deep team across the entire market access area so I think they have incredible bench strength and I like how their team works together to come up with legal advice.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

  • The firm's lawyers have first-hand in-house and government experience that is critical to their credibility as advisers. They are creative and understand our business and our business objectives.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

  • I can go to them for anything and I know I'll get highly skilled, highly knowledgeable client service. All the folks I worked with are super smart, approachable, humble, and easy to work with.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

Notable Practitioners

Provided by Chambers

  • Allison W Shuren
    Allison W Shuren

    Allison W Shuren

    Allison Shuren maintains an active practice in FCA investigations, qui tam lawsuits and compliance review. She is particularly adept at advising organizations in the ophthalmic sector.

    • Allison is knowledgeable, practical and always available.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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  • Daniel Kracov
    Daniel Kracov

    Daniel Kracov

    Daniel Kracov is known for his expertise in regulatory matters involving medical device and pharmaceutical companies. His practice spans a wide range of issues, including FDA approvals and data privacy matters.
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  • Jeffrey L Handwerker
    Jeffrey L Handwerker

    Jeffrey L Handwerker

    Jeffrey Handwerker has a thriving regulatory practice and frequently handles federal qui tam litigation, as well as wider pricing and reimbursement mandates.

    • Jeffrey is knowledgeable in the space and one of the best advocates.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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  • Mahnu Davar
    Mahnu Davar

    Mahnu Davar

    Mahnu Davar has experience in various issues including Emergency Use Authorizations, healthcare transactions, and government investigations.

    • Mahnu has an exceptional level of sophistication in the advice he provides, based on his in-depth industry knowledge and knowledge of the regulatory landscape.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

    • Mahnu is an excellent lawyer with deep expertise in the pharmaceutical industry, particularly in the area of FDA and clinical trial activities.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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  • Howard Sklamberg
    Howard Sklamberg

    Howard Sklamberg

    Howard Sklamberg is highlighted for his ability to assist pharmaceutical organizations and manufacturers with FDA compliance and inspections.
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  • Eva Temkin
    Eva Temkin

    Eva Temkin

    Eva Temkin focuses her practice on advising biotechnology and pharmaceutical organizations on FDA regulations and litigation.

    • Eva is an FDA expert. She has her finger on the pulse in DC; she is very smart, very thoughtful and has good temperament on adversarial perspectives.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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  • John Gould
    John Gould

    John Gould

    John Gould handles regulatory issues for healthcare clients, with a focus on drug price reporting compliance and obligations. His clients include biological and medical device manufacturers.

    • John has exceptional awareness of our business needs and a great track record of success in government interactions on our behalf.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

    • John is incredibly flexible, an excellent listener and excellent on follow-ups.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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  • Kristin M Hicks
    Kristin M Hicks

    Kristin M Hicks

    Kristin Hicks is highly regarded for guiding pharmaceutical and medical device clients through complex compliance, pricing, and policy changes. She is also experienced in defending clients in fraud and abuse litigation.

    • Kristin provides excellent counsel and practical advice.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

    • Kristin is terrific. She gives practical advice and is responsive.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
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Ranked Individuals at Arnold & Porter (8)

District of Columbia

  • Profile image of Daniel Kracov

    Daniel Kracov

    Healthcare: Pharmaceutical/Medical Products Regulatory

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  • Profile image of Jeffrey L Handwerker

    Jeffrey L Handwerker

    Healthcare: Pharmaceutical/Medical Products Regulatory

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  • Profile image of Mahnu Davar

    Mahnu Davar

    Healthcare: Pharmaceutical/Medical Products Regulatory

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  • Profile image of Howard Sklamberg

    Howard Sklamberg

    Healthcare: Pharmaceutical/Medical Products Regulatory

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  • Profile image of Eva Temkin

    Eva Temkin

    Healthcare: Pharmaceutical/Medical Products Regulatory

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  • Profile image of John Gould

    John Gould

    Healthcare: Pharmaceutical/Medical Products Regulatory

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  • Profile image of Kristin M Hicks

    Kristin M Hicks

    Healthcare: Pharmaceutical/Medical Products Regulatory

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Members

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