FDA Modernization Act 3.0

# FDA Modernization Act 3.0 Summary **What It Does** This bill directs the FDA to update its rules to allow pharmaceutical companies to use alternatives to animal testing when developing new drugs. Specifically, it requires the FDA to replace language in its regulations that mandates or assumes animal testing with language allowing "nonclinical tests"—which includes lab-based methods, computer models, and other alternatives. The FDA must complete these regulatory changes within one year of the bill becoming law. **Who It Affects** The bill primarily impacts pharmaceutical and biotech companies developing new drugs, as well as researchers and the FDA itself.

It could indirectly benefit animal welfare advocates and potentially speed up drug development by allowing companies to use faster or more efficient testing methods. Patients awaiting new medications might benefit from accelerated timelines, though the bill maintains FDA oversight of drug safety. **Key Point & Status** This bill codifies a provision from the 2023 federal spending bill and essentially modernizes FDA regulations to catch up with existing scientific alternatives to animal testing. The Senate has already passed it; it now awaits action in the House of Representatives.