FDA Modernization Act 2.0

Congress has passed the FDA Modernization Act 2.0 as part of the recent omnibus bill, removing the requirement to use animal testing in drug development. This allows drug companies to use alternative safety-testing models, such as cell-based assays, organ chips and microphysiological systems, and sophisticated computer modeling. Proponents state these alternatives are cost-effective and provide a more accurate assessment of the safety of a drug, and can help reduce the time and cost of bringing drugs to market. It hopes to afford researchers the ability to optimize trial design and dosing for different patient populations, and ultimately result in the faster development of lifesaving drugs and vaccines.

Critics however are more circumspect citing the inability to adequately test drug efficacy and safety without clinical trials. This notwithstanding, however, it is now law. Expect more drugs to be flooding the healthcare marketplace soon – with safety and efficacy to be determined.

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