William E. Holtz
Of Counsel
William (Bill) Holtz is a seasoned life sciences and U.S. Food and Drug Administration (FDA) regulatory and policy strategist. He provides clients with practical advice on regulatory matters, drawing on years of experience both in private practice and as a regulator. Bill has deep knowledge of the health product regulatory environment, including medical product regulation, clinical research, product life cycle management, digital technologies, and compliance.
Prior to joining Foley, Bill served as a division director in FDA’s Center for Drug Evaluation and Research, Office of Medical Policy, where he managed a portfolio of regulatory health policy programs. Previously, Bill spent over two decades providing strategic FDA regulatory development and policy consulting for biotechnology, medical device, and health care technology companies.
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FDA Considers Drug Pricing: Leadership Cites Consumer Cost as a Driver for Changes to Biosimilar Recommendations
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FDCA: Fifth Circuit End-run Suggests State Law Private Right of Action
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FDA on the Offense! Targeting Pharmaceutical Company Drug Advertising in Wave of Enforcement Actions
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DOJ Consumer Branch's End Leaves FDA Litigation Questions

FDA Calls for Stronger Industry Collaboration on Infant and Child Food Recalls
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