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The former acting director of the FDA ODSP will co-lead the firm’s regulatory practice with partner Rend Al-Mondhiry.
July 8, 2024
By: Mike Montemarano
Robert “Bob” Durkin, an attorney who formerly served as the acting director of the U.S. Food and Drug Administration (FDA)’s Office of Dietary Supplemnet Programs (ODSP), has joined the law firm Amin Wasserman Gurnani (AWG) as partner and co-chair of its regulatory group in Washington, D.C.
Durkin will co-lead the regulatory practice alongside Rend Al-Mondhiry, firm partner and longstanding regulatory group team member.
Durkin spent 12 years at FDA, in roles such as acting director and deputy director of the ODSP in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). His role involved policy analysis and evaluations across all aspects of the agency’s dietary supplement programs, and spearheading programs on compliance and enforcement, including warning letters, seizures, injunctions, and import detention/refusal.
He participated in various agency working groups, including the marijuana working group, the CBD policy working group, and the investigational new drug (IND) policy working group. Durkin guided ODSP through several Government Accountability Office (GAO) investigations.
As the acting director of CFSAN’s food defense staff, Durkin steered the team responsible for determining the best regulatory strategies to protect the nation’s food supply from intentional contamination.
“Attracting nationally recognized leaders like Bob is a testament not only to our work on the most sophisticated matters before the Food and Drug Administration, Federal Trade Commission, National Advertising Division, and in the courts, but also to our culture,” said Ivan Wasserman, managing partner. “Like Rend, Bob‘s longstanding dedication to the industries we serve and his ‘team first’ approach make him an ideal fit for our firm. Bob further enhances our ability to partner with clients to unravel the complexities of FDA compliance while mitigating the risks associated with the design, labeling, and promotion of their products in the hyper-competitive health and wellness markets.”
“We are thrilled to have Bob join us,” said Al-Mondhiry. “With his knowledge of FDA’s inner workings, clients will benefit from his insights and ability to ‘see around corners’ for them while navigating the intricacies of an ever-changing FDA landscape.”
“AWG has a standout practice representing clients subject to FDA oversight,” said Durkin. “I look forward to strengthening the group’s powerhouse status alongside Rend. She builds and explains longstanding client relationships, and her entrepreneurial drive is second to none. I was also attracted to the firm’s reputation for excellence and its supportive and collaborative culture and couldn’t be more excited to joint this dynamic team.”
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