GAIN TOOLS Act of 2022
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Generating Antibiotic Incentives Now Through Opening Opportunities to Leverage Science Act of 2022 or the GAIN TOOLS Act of 2022
This bill expands the definition of a qualified infectious disease product (QIDP) to include eligible biological products. Under current law, the first application (or supplement) for a specific product and indication to be designated a QIDP shall receive priority review for market approval by the Food and Drug Administration.
Generally, a biological product designated as a QIDP is one that acts on bacteria or fungi and is intended to treat a serious or life-threatening infection.
However, a biological product with a QIDP designation shall not receive the market exclusivity extension currently available to drugs that receive the designation.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Introduced in Senate Formatted Text PDF Formatted XML
Cite this page
U.S. Congress. (2026). S. 3478: GAIN TOOLS Act of 2022. 117th Congress. Open America. https://openamerica.io/bill/117-S-3478/
"S. 3478: GAIN TOOLS Act of 2022." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-S-3478/.
S. 3478, 117th Cong. (2026), https://openamerica.io/bill/117-S-3478/.
[S. 3478: GAIN TOOLS Act of 2022](https://openamerica.io/bill/117-S-3478/)