Hoofdfoto van Bill Holtz.

William E. Holtz

Van Advies

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.

10 november 2025 Gezondheidsrecht vandaag

FDA overweegt prijsstelling geneesmiddelen: De leiding noemt de kosten voor de consument een drijfveer voor veranderingen in de aanbevelingen voor biosimilars

"Door het biosimilar ontwikkelingsproces te stroomlijnen en de uitwisselbaarheid te bevorderen, kunnen we enorme kostenbesparingen...
14 oktober 2025 Gezondheidsrecht vandaag

FDCA: einde van Fifth Circuit suggereert privaatrechtelijk vorderingsrecht van de staat

Biowetenschappelijke bedrijven die benadeeld zijn door activiteiten van concurrenten die vermoedelijk in strijd zijn met de Federal, Food, Drug, and Cosmetic Act (FDCA)...
12 september 2025 Gezondheidsrecht vandaag

FDA in de aanval! Farmaceutische bedrijven richten zich op geneesmiddelenreclame in een golf van handhavingsacties

Op 9 september 2025 hebben het Amerikaanse ministerie van Volksgezondheid en Human Services (HHS) en de Amerikaanse Food & Drug Administration (FDA) duizenden...
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...
12 augustus 2025 Gezondheidsrecht vandaag

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...