Boost FDA Modernization Act 2.0 Readiness With an Advanced LIMS

Home Resources LIMS Publications Boost FDA Modernization Act 2.0 Readiness With an Advanced LIMS

Author: Shonali Paul

Journal: Technology Networks, August 26, 2025

Abstract: April was a remarkable month for both the scientific and regulatory communities in clinical research. The FDA finally set concrete plans for implementing the FDA Modernization Act 2.0, bringing us steps closer to the end of mandatory animal testing in preclinical studies. In the same month, the NIH launched an initiative to prioritize human-based research technologies over animal-based research technologies. The NIH noted that human-based research, either in isolation or in combination with animal research, will help to provide more clinically relevant results. These changes reflect growing concerns about the limitations of animal models and the need for more human-relevant testing methods.

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