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    Arent Fox Expands FDA Practice with Addition of Two Former Agency Officials

    January 26, 2017

    Washington, DC – Arent Fox LLP is pleased to announce the addition of counsel Brian J. Malkin and senior attorney Paul S. Gadiock as members of the firm’s nationally recognized Food, Drug, Medical Device & Agriculture practice. Mr. Malkin will continue to focus his practice on counseling drug and biologics companies on the interrelation between patent law and food and drug law, while Mr. Gadiock will help provide regulatory solutions to the firm’s medical device clients on a variety of issues.

    “Brian and Paul are well-respected, talented former FDA officials who are welcome additions to our growing practice,” said FDA practice leader James R. Ravitz. “Arent Fox is increasingly recognized as a go-to firm for matters involving the food, drug, medical device and agriculture industries in part because we have built the group around former agency officials, putting the firm in a unique position among elite FDA groups in the national market.”

    Mr. Malkin arrives from McGuireWoods, where he led the firm’s FDA regulatory team. His experience involves all types of FDA-regulated products, including drugs, biologics, medical devices, foods and dietary supplements, tobacco products, and cosmetics. Mr. Malkin’s intellectual property experience includes FDA and patent litigation for both innovator and generic companies. As an advisor to innovator drug companies, Mr. Malkin has helped clients create strategies for approval of new drug applications, reviewed existing patent portfolios, and developed risk management programs.

    Mr. Malkin began his legal career as a regulatory counsel at FDA, where he worked for more than nine years in both the Office of the Commissioner and the Center for Drug Evaluation and Research and focused on new product evaluations, compliance issues related to clinical investigations and intellectual property (e.g., patent term restoration). He received his law degree from The George Washington University Law School.

    Mr. Gadiock comes to Arent Fox from the FDA’s Center for Devices and Radiological Health, where he served as the Associate Director for Policy. As a former policy director, Mr. Gadiock brings first-hand experience with major regulatory programs and frameworks, including advising key agency officials on issues related to existing and proposed policies, programs, regulations, and legislation. He received his JD from The University of Maryland School of Law and his Bachelor of Science degree in Physiology & Neurobiology from University of Maryland, College Park.

    Arent Fox has one of the premier Food, Drug, Medical Device & Agriculture regulatory teams in the US. Staffed with over 40 professionals, the group offers a full range of regulatory, transaction, and litigation services for manufacturers, distributors, and retailers of food, dietary supplements, pharmaceuticals, biologics, medical devices, cosmetics, personal care products, and chemical products.