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# Draft Guide on Qualified Infectious Disease Designations
- URL: https://www.fdaweb.com/draft-guide-on-qualified-infectious-disease-designations/
- Published: 2018-01-29T12:00:00.000Z
- Updated: 2026-09-14T23:17:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140623

FDA has released a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM594213.pdf?ref=fdaweb.com) on “Qualified Infectious Disease Product Designation Questions and Answers.” The document provides information on implementing the FDA Safety and Innovation Act’s section on “Generating Antibiotic Incentives Now (GAIN),” which creates incentives for developing antibacterial and antifungal drug products that treat serious or life-threatening infections.” It also covers the agency’s policies and procedures related to the designation of a qualified infectious disease product under GAIN. Such designated products are eligible for a five-year exclusivity extension and a priority review.