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Bill Holtz

Of Counsel

About me

1/27/2026 8:40:10 PM

By Jessa Boubker Nate Beaver Bill Holtz +1 more...

On January 6, 2026, the U.S. Food & Drug Administration (FDA) updated two guidance documents, General Wellness: Policy for Low Risk...

11/10/2025 2:42:10 PM

By Bill Holtz David Rosen Nate Beaver

“By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for...

10/14/2025 4:20:52 PM

By Bill Holtz Jack Korba David Rosen

Life sciences companies aggrieved by competitor activity believed to be in violation of the Federal, Food, Drug, and Cosmetic Act (FDCA)...

9/12/2025 3:15:38 PM

By Jessa Boubker Bill Holtz Nate Beaver +1 more...

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

8/15/2025 2:48:11 PM

By Jack Korba Bill Holtz David Rosen

This article was originally published in Law360 on August 11, 2025, and is republished here with permission. With the dissolution of the...

8/12/2025 3:23:10 PM

By David Rosen Bill Holtz Nate Beaver

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...