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S 1462 117th Congress Senate Health Drug safety, medical device, and laboratory regulation Licensing and registrations Prescription drugs

Simplifying the Generic Drug Application Process Act

Introduced: April 29, 2021 Introduced by: Cassidy, Bill Republican · Louisiana 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 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 29, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 29, 2021
Introduced in Senate
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 Plain-English summary Congressional Research Service

Simplifying the Generic Drug Application Process Act

This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug.

Currently, if an applicant wishes to submit an abbreviated application (i.e., the type of application typically used to get market approval for a generic drug) for a drug that has a different dosage form or strength from an already-approved drug, the applicant must first petition the FDA for permission to submit the application. Under this bill, an applicant is no longer required to petition the FDA for permission in these instances.

What's happening now April 29, 2021

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 1
All 1 Democratic 1
D
Smith, Tina
Minnesota · Apr 29, 2021
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1462: Simplifying the Generic Drug Application Process Act. 117th Congress. Open America. https://openamerica.io/bill/117-S-1462/
MLA
"S. 1462: Simplifying the Generic Drug Application Process Act." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-S-1462/.
Bluebook (legal)
S. 1462, 117th Cong. (2026), https://openamerica.io/bill/117-S-1462/.
Markdown link
[S. 1462: Simplifying the Generic Drug Application Process Act](https://openamerica.io/bill/117-S-1462/)
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