Zdrowie i gospodarka · 05/06/2014

FDA Establishes List of Qualifying Pathogens Under FDASIA

The Food and Drug Administration (FDA) is issuing a regulation to identify pathogens that pose a serious threat to public health, in line with the Generating Antibiotic Incentives Now (GAIN) provision of the Food and Drug Administration Safety and Innovation Act (FDASIA). The list includes 18 pathogens, including Acinetobacter species, Aspergillus species, and Mycobacterium tuberculosis complex, which will be eligible for fast-track designation and extended exclusivity.