GAIN TOOLS Act of 2022

[AI summary unavailable — showing source text] 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.…