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S. 5002

FDA Modernization Act 2.0

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.

Held at the desk.

Sen. Paul, Rand [R-KY](R-KY)Sponsor
11 cosponsors3 D6 R2 I
11cosponsors6actions2related bills5subjects
  1. FloorH15000

    Held at the desk.

  2. FloorH14000

    Received in the House.

  3. Floor

    Message on Senate action sent to the House.

  4. Floor

    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)

  5. Floor17000

    Passed/agreed to in Senate: Introduced in the Senate, read twice, considered, read the third time, and passed without amendment by Unanimous Consent.

  6. IntroReferral10000

    Introduced in Senate

Sep 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.

Sep 29, 202255

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.

FDA Modernization Act 2.0 — Informed