Healthcare: Pharmaceutical/Medical Products Regulatory
USA Guide 2024 : District of Columbia
Band 2
Contact number
+1 202 942 5000Chambers Review
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 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
"Arnold & Porter are incredibly responsive and strategic."
"The Arnold & Porter team is efficient and effective."
"The team has strong service levels and responsiveness."
"Arnold & Porter are incredibly responsive and strategic."
"The Arnold & Porter team is efficient and effective."
"The team has strong service levels and responsiveness."
Notable Practitioners
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 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 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 is highlighted for his ability to assist pharmaceutical organizations and manufacturers with FDA compliance and inspections.
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 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
District of Columbia
Members
Provided by Arnold & Porter