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
April 3, 2020
Update on Medical Products Shortage Reporting: What Manufacturers Need to Know Regarding FDA's New Reporting Guidance and Expanded Reporting Under the CARES Act
Coronavirus: Life Sciences and Healthcare Regulatory Advisory
January 24, 2020
A New Private Right of Action is Created for Refusals to Provide Drugs and Biologics to Certain Product Developers
Advisory
December 23, 2019
Questions & Answers Guide to FDA’s Prescription Drug Importation Proposals
Advisory
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