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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.

October 7, 2026 In the News

William Holtz Examines New FDA Approach to Clinical Trial Development

Foley & Lardner LLP of counsel William Holtz is quoted in the PharmaVoice article, “5 Key Facts About the FDA Expedited IND Pilot Program,” examining the FDA's new pilot program and its potential to accelerate clinical research.
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September 23, 2026 Foley Viewpoints

FDA Medical Devices: Important Regulatory Considerations for Companies Seeking to Enter the U.S. Market

The medical device market in the U.S. is very large and attractive to many companies who are located outside of the U.S. Entering the U.S. medical device market requires a comprehensive, integrated strategy that goes beyond U.S. Food and Drug Administration (FDA) product clearance or approval — an effective market strategy must address key regulatory, quality, reimbursement, and commercial considerations.
July 23, 2026 In the News

William Holtz Quoted on Potential Regulatory Shifts for Peptide Compounding

Foley & Lardner LLP of counsel William Holtz was quoted in Reuters on the FDA advisory committee's review of potential changes to peptide compounding regulations.
June 23, 2026 In the News

William Holtz on Regulatory Balance in Peptide Market

Foley & Lardner LLP of counsel William Holtz was quoted in The Wall Street Journal’s article, “Businesses Are Taking Risks to Cash In on the Peptide Gold Rush,” examining the risks and regulatory challenges facing compounding pharmacies supplying peptides.
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May 5, 2026 Health Care Law Today

FDA to Consider Lifting Restrictions on Numerous Compounded Peptides

On April 16, 2026, the U.S. Food & Drug Administration (FDA) announced it will convene the Pharmacy Compounding Advisory Committee (PCAC) on July 23 and 24, 2026, to discuss permitting compounding pharmacies to prepare certain peptides used for ulcerative colitis (UC), wound healing, obesity, insomnia, opioid withdrawal, inflammatory conditions, and osteoporosis, among other conditions.
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April 28, 2026 Health Care Law Today

Psychedelics and the Executive Order: From Schedule I to Treatment Priority

The Order represents a significant federal policy shift aimed at addressing what the Trump Administration describes as a crisis of serious mental illness in America.