In brief

As we look back at 2023, we reflect on a year marked by significant developments in the legal framework governing the life sciences and healthcare industries in the US. These developments include the implementation of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act; the rise of artificial intelligence in drug development and manufacturing; the evolving landscape of US Food and Drug Administration regulation and enforcement of laboratory-developed tests; and the new general compliance program guidance issued by the US Department of Health and Human Services Office of Inspector General.


In this article, published in Law360, Xin Tao and Lois Sheng Liu explore these topics, which they expect to dominate 2024 as well.

Author

Xin Tao is a member of Baker McKenzie's North America Steering Committee for Healthcare & Life Sciences, and currently heads our US Food and Drug Law Practice.

Author

Lois is a member of the Firm's Litigation & Government Enforcement Practice Group in the FDA sub-group, based in Washington, DC.