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BioWorld - Thursday, May 14, 2026
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Home » FDA likely to see more legal challenges to rulemaking, guidance in 2025
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End of Year

FDA likely to see more legal challenges to rulemaking, guidance in 2025

Dec. 23, 2024
By Mark McCarty
The U.S. FDA’s authority was challenged on a number of occasions over the past few decades, but the rate is likely to pick up as the U.S. Supreme Court ruled recently that the agency cannot take judicial deference for granted any longer. Chad Landmon of the D.C. office of Polsinelli told BioWorld that future litigation against the FDA may extend even to sub-regulatory guidance thanks to the outcome in the case of Loper Bright – a scenario in which industry might carve out a few significant wins in the coming year.
Medical technology Regulatory U.S. FDA

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