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.
Associate Elizabeth J. Perkins contributed to this newsletter.
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