Brian J. Malkin has joined Arent Fox’s food, drug, medical device and agriculture practice. Among other things, he will advise customers on the interrelation between patent law and food and drug law.
Previously, Malkin was with McGuireWoods, where he led the firm’s Food and Drug Administration regulatory team. His regulatory experience includes all types of FDA-regulated products, including drugs, cosmetics and tobacco.
Malkin’s intellectual property experience includes FDA and patent litigation for both innovator and generic companies. As an advisor to innovator drug companies, he has helped clients create strategies for approval of new drug applications, reviewed existing patent portfolios, and developed risk management programs.
Malkin began his legal career as a regulatory counsel at the FDA, where he worked for more than nine years in both the Office of the Commissioner and the Center for Drug Evaluation and Research. At the FDA, he focused on new product evaluations, compliance issues related to clinical investigations, and intellectual property.
He received his law degree from The George Washington University Law School.