Life Sciences: Regulatory/Compliance
USA Guide 2024 : USA - Nationwide
Band 1
Contact number
212 836 8000Chambers Review
Arnold & Porter has a high quality team encompassing patent prosecution and regulatory compliance expertise. The firm offers a strong contentious practice for matters such as post-grant reviews and infringement allegations, and has experience representing clients on licensing deals, financing rounds and M&A, with additional expertise in defending product liability claims.
Work Highlights
- Arnold & Porter represented AstraZeneca in litigation under the Administrative Procedure Act challenging an HHS determination that AstraZeneca is required to recognize sales to pharmacies as sales under the 340B program.
Strengths
Provided by Chambers
"Arnold & Porter's deep bench of experts do an excellent job of handling complex matters. Their strategic approach enables all aspects of complex matters be covered, and brought forward in a logical way to ensure that client concerns are covered."
"The Arnold & Porter team is uniquely positioned to give thoughtful regulatory advice as well as litigation advice. They constantly produce excellent work."
"Arnold & Porter's deep bench of experts do an excellent job of handling complex matters. Their strategic approach enables all aspects of complex matters be covered, and brought forward in a logical way to ensure that client concerns are covered."
"The Arnold & Porter team is uniquely positioned to give thoughtful regulatory advice as well as litigation advice. They constantly produce excellent work."
Notable Practitioners
Daniel Kracov is experienced at handling investigations, compliance programs and transaction due diligence for trade associations and businesses of all sizes.
Eva Temkin chairs the firm's FDA practice and has substantial experience in a wide range of FDA-related matters, including regulatory proceedings, transactions and complex disputes.
Jeffrey Handwerker has a wide-ranging practice advising household name pharmaceutical manufacturers on regulatory and compliance issues. He offers support to clients seeking advisory opinions and defending against False Claims Act litigation.
"Jeffrey Handwerker is a very well regarded regulatory lawyer."
"His support in the regulatory and government investigations space has been tremendous."
Matthew Wolf regularly advises large pharmaceutical companies on patent prosecution and patent validity litigations.
Ranked Lawyers at
Arnold & Porter
USA - Nationwide