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
October 17, 2022
FDA Releases Significantly Revised Final Clinical Decision Support Software Guidance and Related Changes
Advisory
September 2022
USA: Law and Practice Chapter (pdf)
Medical Devices & Consumer Health Products 2022, Chambers Global Practice Guides
September 15, 2022
FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics
Arnold & Porter and Lachman Consultants
April 7, 2022
Harmonisation of International Rules on Medical Device Quality Management Systems
BioSlice Blog
September 2021
USA: Law and Practice Chapter (pdf)
Medical Devices & Consumer Health Products 2021 Guide, Chambers & Partners
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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