In order to counter the threat of antibiotic resistance, the US Congress implemented Title VIII of the US Food and Drug Administration Safety Innovation Act (FDASIA), the Generating Antibiotic Incentives Now Act (GAIN Act) of 2012. The GAIN Act encourages the development of products to treat antibiotic resistant infections and provides incentives and additional guidance to pharmaceutical companies to develop Qualified Infectious Disease Products (QIDPs).
A QIDP, as defined in the GAIN Act, is an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections caused by but not limited to certain qualifying pathogens.
In this whitepaper, our expert outlines how to craft a successful QIDP designation application, what advantages designation offers, and why it’s worth considering specialized support.
Written By:
Teonia Jarrett, PharmD, MBA
