Generating Antibiotic Incentives Now, Required by Section 805 of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144 [open pdf - 545KB]
"Generating Antibiotic Incentives Now (GAIN) was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). It addresses the public health threat of antibacterial drug resistance by stimulating the development and approval of new antibacterial and antifungal drugs. [...] This report describes the progress made in facilitating the development and approval of new antibacterial drugs and implementing stewardship programs to ensure their judicious use, and it assesses the incentives available under GAIN five years following enactment."
Food and Drug Administration: https://www.fda.gov/