Chambers Review

Provided by Chambers
Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia
2
Band 2
What the team is known for

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

Provided by Arnold & Porter
  • Arnold & Porter acted as strategic regulatory, compliance and transactions counsel to Enzyvant in connection with manufacturing, supply, procurement and launch activities for RETHYMIC®.

Strengths

Provided by Chambers

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.

"She has expertise in some of the most nuanced areas and her advice is practical."

"Allison is very experienced and knowledgeable."

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.

"Dan has so much perspective and wisdom to impart."

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.

"Jeffrey is very knowledgeable on healthcare regulation and litigation."

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.

Mahnu Davar
4
Mahnu Davar
4
Band 4

Mahnu Davar is an up-and-coming attorney with growing experience in various issues including Emergency Use Authorizations, healthcare transactions, and government investigations.

"Mahnu has deep industry knowledge and he is an excellent strategic thinker."

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 a top-notch FDA lawyer with a wide depth and breadth of knowledge. She is an invaluable partner on tricky issues."

"She's a fabulous lawyer."

Ranked Lawyers at
Arnold & Porter

Provided by Chambers
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Band

District of Columbia

Healthcare

Allison W Shuren
1
Allison W Shuren
1
Band 1
Healthcare: Pharmaceutical/Medical Products Regulatory

Daniel Kracov
1
Daniel Kracov
1
Band 1
Jeffrey L Handwerker
1
Jeffrey L Handwerker
1
Band 1
Howard Sklamberg
4
Howard Sklamberg
4
Band 4
Mahnu Davar
4
Mahnu Davar
4
Band 4
Eva Temkin
5
Eva Temkin
5
Band 5