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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.

Three glass vials with clear liquid and blue caps are next to a syringe, with one vial lying on its side—often seen in cases reviewed by Chicago lawyers handling medical evidence.
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.
A person wearing blue gloves arranges labeled blood sample tubes in a laboratory setting, providing crucial litigation support for lawyers in Chicago.
April 28, 2026 Health Care Law Today

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

On April 18, 2026, President Donald Trump signed an executive order titled Accelerating Medical Treatments for Serious Mental Illness, directing federal agencies to expedite the research, review, and approval of psychedelic drugs as potential treatments for serious mental health conditions. 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, with particular emphasis on patients whose conditions have not responded to standard therapies.
April 27, 2026 In the News

David Rosen and William Holtz Analyze FDA Approval Speed, Biotech Pressures

Foley & Lardner LLP attorneys David Rosen and William Holtz are quoted in the PharmaVoice article, “FDA’s need for speed could strain small biotechs. Here’s how they can keep up,” examining the FDA’s accelerated drug approval initiatives and its impact on smaller pharmaceutical 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...