GAIN TOOLS Act of 2022

Hozzl · 2024-03-13T02:29:41Z

Explore the details of Senate Bill 3478 GAIN TOOLS Act of 2022 currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

3/13/2024, 2:29 AM

Congressional Summary of S 3478

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.

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Current Status of Bill S 3478

Bill S 3478 is currently in the status of Bill Introduced since January 11, 2022. Bill S 3478 was introduced during Congress 117 and was introduced to the Senate on January 11, 2022. Bill S 3478's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of January 11, 2022