Navigating Administrative Law: Understanding the Basics of Challenging Federal Agency Decisions

Introduction In the complex landscape of governance, federal agencies wield significant authority in executing and enforcing laws enacted by Congress. These agencies, however, are subject to oversight through administrative law, which provides a structured framework for individuals and entities to contest agency decisions. This article aims to explain some foundational principles of challenging federal agency […]

Recent Developments in Medical Device Patent and FDA Law

Patent litigation in the medical device area continues. Along with pharmaceutical patent litigation, medical device patent litigation continues to provide important rulings and case law precedent. Because of the large-scale investment needed to bring medical devices to the market, device sponsors need certainty about the law and its application to ensure a return on the […]

Patent Infringement Damages and Injunctions – The Basics

Patents, as one part of intellectual property protection, provide a valuable property right and play an important role in economic development, a reward for innovations, add to the technological knowledgebase, and increase the general welfare. Patentees obtain patents for defensive purposes (file applications for publication and issuance to create prior art against others); commercial purposes […]

FDA’s 505(b)(2) Application

The 505(b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy for clients. This hybrid NDA application helps avoid duplicative and costly studies that others have already completed. FDA’s rules allow (b)(2) applicants to rely on this prior body of work. And because of this reliance, the (b)(2) development is cheaper and faster […]

Staying Compliant with FDA’s Good Manufacturing Practice (GMP), and Handling Violations

We concentrate a large part of our work helping clients to solve legal problems when dealing with FDA compliance. Particularly, we help clients comply with the myriad of FDA statutes, regulations, and policies as they relate to drugs and devices. This includes helping with financial, operational, marketing, and investigatory/enforcement issues. Our particular focus is helping clients […]