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FDA Strategy, Compliance and Enforcement

Arnold & Porter is renowned for working with drug, biologic, medical device, diagnostic, food, dietary supplement, cosmetic, and other FDA-regulated companies to determine how their products will be regulated, design product development strategies to minimize review time and assist in optimal presentation of evidence to gain FDA approval or clearance. Our capabilities include developing regulatory strategies for approval or clearance of novel and combination products, advising on FDA-related patent listing and exclusivity matters, navigating the biosimilars framework, counseling on labeling and safety issues, seeking designations for orphan status or expedited approval, and advising on post-market obligations. We have decades of experience representing clients in shaping and challenging regulatory agency policies and responding to enforcement. We have extensive experience with the FDA dispute resolution processes, and have initiated litigation proceedings against the FDA to reverse improper agency decisions.

  • Depth of Experience: The team includes former senior FDA officials and counsel, as well as others with decades of experience in addressing the most complex FDA matters.

  • Thought Leaders: Our lawyers have helped our clients advance important changes to the regulation of biomedical products, from bringing critical First Amendment challenges to shaping new pathways for novel product approvals.

  • Strong Advocates: We have successfully assisted our clients in some of the most challenging FDA enforcement matters, including in matters involving simultaneous FDA, criminal and congressional investigations.