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FDA Modernization Act 3.0

Official title: A bill to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.

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Where the Bill Stands

  1. Introduced, done
  2. Committee, done
  3. Floor Vote, done
  4. Outcome, current stage

What This Bill Does

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.

Sponsors

Related Documents

Bill on Congress.govWeb Page ↗ (opens in a new tab)

Timeline

  1. SenateMessage on Senate action sent to the House.
  2. House floor actionsReceived in the House.
  3. SenateSenate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
  4. Library of CongressPassed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
  5. Floor Vote
  6. Passed the Senate
  7. Library of CongressIntroduced in Senate
  8. SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.
  9. Introduced
  10. Committee

Comments

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