The Nucleus: Life Sciences Enforcement and Regulatory Updates

Skadden Publication

Avia M. Dunn Maya P. Florence Bradley A. Klein John A.J. Barkmeyer Nicole L. Grimm

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including:

  • The growing circuit splits over the False Claims Act causation standard for Anti-Kickback Statute-based cases.
  • A look back at DOJ’s life sciences enforcement activity in 2023.
  • New questions about judicial deference to FDA’s scientific and regulatory expertise based on trends in recent court cases.
  • The first steps towards authorizing importation of prescription drugs from Canada.
  • Finalized amendments to the Quality System Regulation for medical devices.
  • Plans for wide-reaching FDA reorganization in 2024.
  • HHS-OIG’s General Compliance Program Guidance and notable recent advisory opinions. 
  • Key HHS and FTC developments relating to cybersecurity and the sale of sensitive health app data.     

Read the newsletter.

Associate Elizabeth J. Perkins contributed to this newsletter.

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