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S 3478 117th Congress Senate Health

GAIN TOOLS Act of 2022

Introduced: January 11, 2022 See on congress.gov
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jan 11, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jan 11, 2022
Introduced in Senate
 Plain-English summary Congressional Research Service

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.

What's happening now January 11, 2022

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

 Committees of jurisdiction 1