FDA Modernization Act 3.0

FDA Modernization Act 3.0

This bill requires the Food and Drug Administration (FDA) to establish a process that supports nonclinical testing methods for drug development that do not involve the use of animals.

Specifically, the FDA must establish a pathway by which entities may apply to have nonclinical testing methods approved for use in a particular context. Qualifying methods must be intended to replace or reduce animal testing and to either improve the safety and efficacy of nonclinical testing or reduce the time to develop a drug. The FDA must issue its decision within 180 days of receiving an application. The FDA must also prioritize the review of applications for drugs that are developed using an approved nonclinical testing method.

The FDA must annually post a report on its website that summarizes the results of the bill's implementation, including the number of applications received, types of methods that were approved, and the estimated number of animals saved as result of these methods.