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Arnold & Porter
Department profile | Arnold & Porter
Healthcare: Pharmaceutical/Medical Products Regulatory

Chambers Review

Provided by Chambers

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

2
Band 2

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.

Work Highlights

  • Arnold & Porter represented Pharmaceutical Research and Manufacturers of America (PhRMA) in connection with the Inflation Reduction Act, challenging the provisions of the IRA that establish a price-setting regime for Medicare Part D and Part B drugs.

Strengths

Provided by Chambers

The team has strong knowledge and the ability to distill issues down with business objectives in mind.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

The firm is excellent and has got an excellent team of lawyers. They excel in responsiveness and are often already keyed in. They know this space very well and they know what the issues are.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

Arnold Porter has great lawyers who are very organized and provide methodical research and excellent analytic and brief preparation. They have extremely high knowledge of the field and players.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

The team is highly knowledgeable, informative, practical, engaging in a positive, respectful and responsive manner, with a great deal of experience in health law, regulation and transactional issues.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

Notable Practitioners

Provided by Chambers

Allison W Shuren
1
Allison W Shuren
1
Band 1
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 exceptional.

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Daniel Kracov
1
Daniel Kracov
1
Band 1
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.

Daniel is the standard by which every other outside counsel should be judged.

Daniel is an expert in his field. He is practical, timely, reasonable and effective.

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Jeffrey L Handwerker
1
Jeffrey L Handwerker
1
Band 1
Jeffrey Handwerker has a thriving regulatory practice and frequently handles federal qui tam litigation, as well as wider pricing and reimbursement mandates.

He is a really skilled lawyer and good at evaluating issues and coming up with arguments. He is both a subject matter expert on drug pricing issues and a litigation strategist and so is invaluable.

Jeffrey has vast and incalculable knowledge of the healthcare system in the US and uses that to devise excellent strategy for clients.

Jeffrey has a great awareness of industry trends and impact to business.

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Mahnu Davar
3
Mahnu Davar
3
Band 3

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

Mahnu is very practical in his guidance and he takes the time to understand the business. He proactively looks for things that will affect us and is very responsive.

Mahnu understands the business side and he will outline the risks. He is very efficient and extremely responsive.

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Howard Sklamberg
4
Howard Sklamberg
4
Band 4
Howard Sklamberg is highlighted for his ability to assist pharmaceutical organizations and manufacturers with FDA compliance and inspections.

Howard has been an incredible support; he has deep understanding of FDA policy and has been able to guide us through regulatory challenges. He provides thorough and concise advice.

Howard is very responsive, pragmatic and provides intelligent advice.

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Eva Temkin
5
Eva Temkin
5
Band 5
Eva Temkin focuses her practice on advising biotechnology and pharmaceutical organizations on FDA regulations and litigation.

Eva is very strategic and really understands the FDA regulations. She'll tell you how it is, is super responsive and great at what she does.

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John Gould
5
John Gould
5
Band 5

John Gould of Arnold & Porter handles regulatory issues for healthcare clients, with a focus on drug price reporting compliance and obligations.

John has really learnt the ins and outs of the company and in the government price reporting area, which is a highly technical, specialized area.

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Ranked Lawyers at
Arnold & Porter

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District of Columbia

Healthcare
Allison W Shuren
1
Allison W Shuren
1
Band 1
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Healthcare: Pharmaceutical/Medical Products Regulatory
Daniel Kracov
1
Daniel Kracov
1
Band 1
View Profile
Jeffrey L Handwerker
1
Jeffrey L Handwerker
1
Band 1
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Mahnu Davar
3
Mahnu Davar
3
Band 3
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Howard Sklamberg
4
Howard Sklamberg
4
Band 4
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Eva Temkin
5
Eva Temkin
5
Band 5
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John Gould
5
John Gould
5
Band 5
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