Phillip V. DeFedele

Phillip DeFedele counsels clients in the life sciences industry on regulatory, transactional, compliance, and enforcement matters. His areas of focus include FDA regulation of drugs, devices, and biologics, fraud and abuse, research and development, advertising and promotion, and compliance programs. Phil also conducts regulatory due diligence in connection with business transactions and assists in drafting and negotiating various contractual arrangements.

Phil assists life sciences companies with regulatory matters throughout the entire product life cycle, including FDA inspections and enforcement and advisory actions as well as matters that are essential for FDA approval, clearance, or licensure. In addition, he has worked on a significant number of life sciences transactions at, and prior to joining, Arnold & Porter that have collectively exceeded US$100 billion in value. His experience in this area includes applying and analyzing applicable FDA requirements while accounting for general contractual, practical, and business considerations in order to draft contractual provisions and revise agreements from a regulatory perspective.