FDA seeking comments on qualifying pathogens for GAIN

FDA will hold a public hearing on Dec. 18 to obtain input on which pathogens should qualify for drug development incentives under the Generating Antibiotic Incentives Now (GAIN) program. FDA is seeking input on how to apply the four factors it must consider in qualifying pathogens: impact on the public health, rate of growth of drug-resistant organisms, increase in resistance rates and morbidity and mortality. GAIN is part of the FDA Safety and Innovation Act, which was signed into law earlier this year. ...