Bill Holtz headshot.

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.

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...
August 12, 2025 Manufacturing Industry Advisor

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

Call to Action. In a letter dated July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a clear call to action for...
August 12, 2025 Health Care Law Today

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

Call to Action. In a letter dated July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a clear call to action for...