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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 advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions...more

FDCA: Fifth Circuit End-run Suggests State Law Private Right of Action

Life sciences companies aggrieved by competitor activity believed to be in violation of the Federal, Food, Drug, and Cosmetic Act (FDCA) have been consistently unsuccessful in challenging these activities in court – this...more

FDA on the Offense! Targeting Pharmaceutical Company Drug Advertising in Wave of Enforcement Actions

On September 9, 2025, the U.S. Department of Health & Human Services (HHS) and the U.S. Food & Drug Administration (FDA) issued thousands of letters warning pharmaceutical companies to remove “misleading” advertisements and...more

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 remains to be fully answered is who will be responsible for litigation matters typically...more

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 manufacturers, distributors, and retailers of infant formula, baby food, and children’s food...more

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