11/10/2025 2:42:10 PM FDA Considers Drug Pricing: Leadership Cites Consumer Cost as a Driver for Changes to Biosimilar Recommendations By Bill Holtz David Rosen Nate Beaver Kyle Faget +1 more... Show less “By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for...
10/14/2025 4:20:52 PM FDCA: Fifth Circuit End-run Suggests State Law Private Right of Action 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 FDA on the Offense! Targeting Pharmaceutical Company Drug Advertising in Wave of Enforcement Actions By Kyle Faget Jessa Boubker Bill Holtz Nate Beaver David Rosen +2 more... Show less 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 DOJ Consumer Branch's End Leaves FDA Litigation Questions 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 FDA Calls for Stronger Industry Collaboration on Infant and Child Food Recalls By David Rosen Kyle Faget Bill Holtz Nate Beaver +1 more... Show less 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...