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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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April 14, 2026 Health Care Law Today

FDA Clarifies Policies for Pharmacy Compounders of GLP-1 Products

On April 1, 2026,the U.S. Food & Drug Administration (FDA) issued a statement clarifying its compliance policy on the  conditions that must be met for compounded drugs to qualify for the exemptions under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
January 27, 2026 Health Care Law Today

Digital Health Policy: FDA Relaxes Restrictions over Wearables and AI Decision Making Tools in Two New 2026 Guidances

On January 6, 2026, the U.S. Food & Drug Administration (FDA) updated two guidance documents, General Wellness: Policy for Low Risk...
November 10, 2025 Health Care Law Today

FDA Considers Drug Pricing: Leadership Cites Consumer Cost as a Driver for Changes to Biosimilar Recommendations

“By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for...
October 14, 2025 Health Care Law Today

FDCA: Fifth Circuit End-run Suggests State Law Private Right of Action

Life sciences companies aggrieved by competitor activity believed to be in violation of the Federal, Food, Drug, and Cosmetic Act (FDCA)...
September 12, 2025 Health Care Law Today

FDA on the Offense! Targeting Pharmaceutical Company Drug Advertising in Wave of Enforcement Actions

On September 9, 2025, the U.S. Department of Health & Human Services (HHS) and the U.S. Food & Drug Administration (FDA) issued thousands...
August 15, 2025 Health Care Law Today

DOJ Consumer Branch's End Leaves FDA Litigation Questions

With the dissolution of the U.S. Department of Justice's Consumer Protection Branch set to occur by Sept. 30, a vital question that...