2025 Top-of-Mind Regulatory Issues for Life Sciences Companies
Life sciences companies are facing significant regulatory shifts following the overturning of the Chevron doctrine by the Supreme Court and new FDA guidance on Laboratory Developed Tests, prompting a focus on enhanced compliance.
Published on April 8, 2025
Life sciences companies are bracing for a transformed regulatory landscape in 2025 following the U.S. Supreme Court's decision on June 28, 2024, to overturn the Chevron doctrine. This ruling, highlighted in cases such as Loper Bright Enterprises v. Raimondo, shifts the balance of statutory interpretation from federal agencies to the judiciary and has widespread implications for how agencies, including the FDA, exercise their powers.
In response to these changes, the FDA has issued updated guidance and enforced new rules regarding Laboratory Developed Tests (LDTs), moving towards a four-year phaseout of its previous enforcement discretion model as of May 2024. Life sciences companies are urged to prioritize compliance as these evolving regulations continue to reshape the industry's approach to ensuring safety and effectiveness in medical devices.