I help life sciences companies navigate regulatory issues and commercial considerations at all stages of the product life cycle.
Matthew provides comprehensive advice to FDA-regulated clients across product classes. He advises drug, biologic, and device manufacturers on topics including clinical trials, manufacturing compliance, product exclusivity, and advertising and promotion. Companies turn to Matthew to develop and evaluate marketing approval strategies for pending New Drug Applications, Biologics License Applications, and medical device submissions including PMAs, De Novos, and 510(k)s. His clients rely on his expertise navigating evolving areas of regulatory focus including cell and gene therapies and artificial intelligence-empowered medical devices.
Matthew has guided life sciences investors, manufacturers, and underwriters through complex, multi-national transactions and assisted clients handling internal and government investigations. He works with companies as they interface with FDA on pre-marketing and post-marketing communications ranging from Pre-Sub meetings to product recall discussions. Matthew, a registered patent attorney, regularly advises clients on the scope, applicability, and interactivity of exclusivities granted by FDA and USPTO. His expertise also extends to the food and dietary supplement space – ensuring product labeling and marketing comply with FDA requirements. He monitors FDA policy and guidance developments and provides actionable takeaways for clients in an ever-shifting regulatory landscape.
U.S. District Court for the Eastern District of Virginia
Other Publications
Co-author, Food and Drug Administration’s Final Food Traceability Rule: What It Says and What It Means for the Future, The Journal of Federal Agency Action, March-April 2023
Co-author, A Practical Guide to FDA’s Food and Drug Law and Regulation, Seventh Edition, Chapter 7, “Pharmacovigilance Requirements for Drugs and Biologics”
Honors & Involvement
HONORS
American Bar Association/Bureau of National Affairs Award for Excellence in Health Law
INVOLVEMENT
Member, Food and Drug Law Institute (FDLI)
Member, University of Miami Alumni Association, Washington, DC Regional Community Board
Member, George Washington University Law Alumni Association Board of Directors
Speaking Engagements
"Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy," Food and Drug Law Institute's Introduction to Biological Products (October 2023)
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