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HR 7377 117th Congress House Health Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government information and archives Prescription drugs

Modernizing Therapeutic Equivalence Rating Determination Act

Introduced: April 4, 2022 Introduced by: Curtis, John R. Republican · Utah See on congress.gov
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 5, 2022
Referred to the Subcommittee on Health.
Apr 4, 2022
Referred to the House Committee on Energy and Commerce.
Apr 4, 2022
Introduced in House
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 Plain-English summary Congressional Research Service

Modernizing Therapeutic Equivalence Rating Determination Act

This bill requires the Food and Drug Administration (FDA) to provide a therapeutic equivalence rating for certain new drug applications if the applicant requests such a rating.

Upon request in the application, the FDA must provide such a rating for a new drug application that relies on information from studies not conducted by the applicant and that the applicant does not have a right to reference or use (commonly referred to as a 505(b)(2) application). The FDA must provide the rating no later than 30 days after the application's approval.

(A drug is a therapeutic equivalent of another if they produce the same clinical effect and have the same safety profile. Typically, for certain generic drugs, the FDA rates the therapeutic equivalence of that generic drug to another drug, such as the brand name version. Currently, an applicant seeking approval of a drug through a 505(b)(2) application typically only receives an equivalence rating by requesting one from the FDA in a separate petition.)

What's happening now April 5, 2022

Referred to the Subcommittee on Health.

 Related & companion bills 1
  • S 1463 Identical bill Modernizing Therapeutic Equivalence Rating Determination Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Democratic 1
D
Craig, Angie
Minnesota · Apr 4, 2022
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 7377: Modernizing Therapeutic Equivalence Rating Determination Act. 117th Congress. Open America. https://openamerica.io/bill/117-HR-7377/
MLA
"H.R. 7377: Modernizing Therapeutic Equivalence Rating Determination Act." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-HR-7377/.
Bluebook (legal)
H.R. 7377, 117th Cong. (2026), https://openamerica.io/bill/117-HR-7377/.
Markdown link
[H.R. 7377: Modernizing Therapeutic Equivalence Rating Determination Act](https://openamerica.io/bill/117-HR-7377/)
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