Venable Expands its FDA Group with the Addition of Jeremiah Kelly and Justin Coen
WASHINGTON, DC—Venable LLP is pleased to announce the expansion of its FDA group with the addition of Jeremiah Kelly and Justin Coen as partners in the Washington, DC office. Mr. Kelly and Mr. Coen are joining the firm from the Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Development Command (USAMRDC).
Mr. Kelly’s practice concentrates on helping companies navigate the FDA’s complex regulatory framework for drugs, biologics, medical devices, and combination products. Mr. Kelly has helped companies from “bench to bedside,” with experience at every stage of product development, from the pre-clinical, clinical, and pre-market application phases to post-market compliance. He has helped his clients obtain FDA approval, licensure, clearance, or authorization of over 20 medical products.
Mr. Coen’s practice focuses on guiding companies through the complexities of drug, biologic, and device development regulated by the FDA. He advises clients on every stage of product development, pre- and post-approval regulatory compliance, and commercialization strategies.
His experience includes evaluating marketing application approaches, marketing exclusivity claims, pre- and post-approval GxP compliance, expedited approval mechanisms, priority review vouchers, product labeling issues, animal rule product development, combination products, and advertising and promotion. Mr. Coen also has extensive experience negotiating research and development, licenses, and purchase contracts, including contracts with the federal government.
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