S. 5002 · 117th Congress · Senate

FDA Modernization Act 2.0

In Congress· Held at the desk.
Introduced
Sep 29, 22
Passed Senate
Sep 29, 22
Passed House
Pending
Sent to President
Pending
Signed into Law
Pending

Executive Summary

FDA Modernization Act 2.0

This bill authorizes the use of certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the Food and Drug Administration to investigate the safety and effectiveness of a drug.

The bill also removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.

Previous Versions

55Sep 29, 2022

FDA Modernization Act 2.0

This bill authorizes the use of certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the Food and Drug Administration to investigate the safety and effectiveness of a drug.

The bill also removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.

Action Timeline

6
  1. SEP 29, 2022IntroReferral

    Introduced in Senate

  2. SEP 29, 2022Floor

    Passed/agreed to in Senate

    Introduced in the Senate, read twice, considered, read the third time, and passed without amendment by Unanimous Consent.

  3. SEP 29, 2022Floor

    Introduced in the Senate, read twice, considered, read the third time, and passed without amendment by Unanimous Consent. (consideration: CR S5514-5515; text: CR S5514-5515)

    5514Yea
    5515Nay
    0NV
  4. SEP 29, 2022Floor

    Message on Senate action sent to the House.

  5. SEP 29, 2022Floor

    Received in the House.

  6. SEP 29, 2022Floor

    Held at the desk.