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FDA’s LDT Final Rule Rejected by Federal District Court in Texas

As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT Final Rule, which phases out the FDA’s enforcement discretion policy for...more

“Chevron is overruled”: Key Takeaways and Implications for the FDA and the Life Sciences Industry

On June 28, 2024, the U.S. Supreme Court unequivocally declared “Chevron is overruled.” In Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce,1 the 6-3 majority dismantled the administrative...more

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