New Incentives for Antibiotic Development
Research efforts to help fight the growing global concern of antibiotic resistance received a much-needed boost last year with the passage of a new Act. Included in the Food and Drug Administration Safety and Innovation Act, which took effect on October 1st, the Generating Antibiotic Incentives Now Act provides an additional five years of market exclusivity, priority review, and fast-track status for antibiotics to treat serious or life-threatening diseases. For a marketing application to be eligible for the extended exclusivity period under the GAIN Act, it must be for an antibacterial or antifungal drug that is designated as a qualified infectious disease product. By: Deborah A. Komlos at Thomson Reuters.