| Abstrakt: |
Historical drug testing protocols utilized animal testing to determine whether drugs were safe and effective for use in humans. However, recognizing that testing drugs on other species is potentially dangerous for humans, troubled by failures, unnecessarily expensive, and time consuming, the FDA Modernization Act 2.0, passed in December 2022, removed animal testing as a requirement for new drug applications. While this was an important step forward, a notable failure of that Act is that it did not go far enough to end animal testing. Accordingly, this Article proposes an FDA Modernization Act 3.0. The FDA Modernization Act 3.0 would ensure the highest level of human safety by making drug development human centered. This would be accomplished by embracing cutting-edge technologies, including cell-based assays, human organ chips, and computer modeling. As proposed, the FDA Modernization Act 3.0 would favor human-centered drug testing by prohibiting animal testing where appropriate alternatives exist and adding a reporting requirement to document researchers' efforts to utilize human-centered testing in lieu of animal testing [ABSTRACT FROM AUTHOR] |
