The Food and Drug Administration (FDA or Agency) will include Coccidioides species on the list of qualifying pathogens for the GAIN Act. GAIN exists to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods.”
More information about the inclusion of Valley Fever in the GAIN Act can be found here.
CONTACT: Maggie Zehring · (202) 680-9613 · email@example.com
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