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, 의약품 가격 책정 고려: 경영진, 바이오시밀러 권장 사항 변경의 동인으로 소비자 비용 언급
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FDCA: 제5순회 최종 판결, 주법상 사적 소송권 제안
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공격에 나선 FDA! 제약회사 의약품 광고를 겨냥한 단속 조치의 물결
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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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