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118-s-5046Introduced
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FDA Modernization Act 3.0

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Summary

Official CRS summary

This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug. The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications, and may make other changes to the regulations as appropriate. The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.

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Bill details

Congress
118
Bill type
s
Introduced
September 12, 2024
Sponsor
Not yet available
Last action
December 16, 2024— Held at the desk.

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