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David M. Fox is a leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products, and controlled substances. He has previously worked at the U.S. Food and Drug Administration (FDA) in the agency's Office of the Chief Counsel as assistant chief counsel for Enforcement and associate chief counsel for Drugs. During his FDA tenure and in private practice, David has been deeply involved in precedent-setting disputes between pioneer and generic drug sponsors under the Hatch-Waxman Act. David works closely with sponsors on novel regulatory pathways and resolving disputes with the agency, and he is also deeply involved in life sciences transactions in assessing the strategic value and compliance status of FDA regulated assets.