FDA Prepares for High Court, Final Rule Moves in Election Year

The nation’s food and drug regulator is set to move forward in 2024 on long-awaited rules and guidances, spurred on by an election year that comes amid a legal battle at the US Supreme Court over the agency’s actions.

The Food and Drug Administration’s plans to regulate lab-developed tests, ban certain tobacco products, clarify guidelines for medical devices and artificial intelligence, and act on drug shortages are among the many tasks stakeholders are following from the agency into the new year.

That work comes with the Supreme Court set to hear an appeal from the FDA regarding a Fifth Circuit ...