Phillip V. DeFedele counsels clients in the life sciences and healthcare industries 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. Mr. DeFedele also conducts regulatory due diligence in connection with business transactions and assists in drafting and negotiating various contractual arrangements.
Perspectives
September 2021
USA: Law and Practice Chapter (pdf)
Medical Devices & Consumer Health Products 2021 Guide, Chambers & Partners
June 11, 2021
White House Details Supply Chain Security and Resiliency Plans: What Pharmaceutical Manufacturers Need to Know
Advisory
November 25, 2020
HHS Finalizes New Protections Under the Stark Law for Value-Based Arrangements and Makes Other Critical Revisions and Clarifications to the Regulations that Physicians and Designated Health Service Entities Must Understand
Advisory
November 23, 2020
Final FDA Guidance Reinforces Increased Focus on Diversity and Inclusion in Clinical Development
Advisory
October 9, 2020
Guide to the Trump Administration's Drug Importation Final Rule and Guidance
Advisory
More
Credentials
Education
- JD, Health Law, Seton Hall University School of Law, 2015, summa cum laude, valedictorian
- BA, History, Italian minor, The College of New Jersey, 2011
Admissions
- New York
- New Jersey