--- title: "Whitepaper: The FDA Qualified Infectious Disease Product (QIDP) Designation" description: Learn how to leverage an FDA qualified infectious disease product designation (QIDP) to expedite your drug product development and regulatory review process from our whitepaper. --- [![pace logo header white](https://info.pacelabs.com/hs-fs/hubfs/pace%20logo%20header%20white.png?width=600&height=410&name=pace%20logo%20header%20white.png) ![pace logo header](https://info.pacelabs.com/hs-fs/hubfs/pace%20logo%20header.png?width=600&height=410&name=pace%20logo%20header.png)](https://www.pacelabs.com) - [Analytical + Environmental](https://www.pacelabs.com/analytical-environmental/) - [Life Sciences](https://www.pacelabs.com/life-sciences/) - [Professional Services](https://www.pacelabs.com/professional-services/) - [Blog](https://blog.pacelabs.com/keeping-pace-with-analytical-services) # The FDA Qualified Infectious Disease Product (QIDP) Designation      In order to counter the threat of antibiotic resistance, the US Congress implemented Title VIII of the US Food and Drug Administration Safety Innovation Act (FDASIA), the Generating Antibiotic Incentives Now Act (GAIN Act) of 2012. The GAIN Act encourages the development of products to treat antibiotic resistant infections and provides incentives and additional guidance to pharmaceutical companies to develop Qualified Infectious Disease Products (QIDPs). A QIDP, as defined in the GAIN Act, is an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections caused by but not limited to certain qualifying pathogens.   In this whitepaper, our expert outlines how to craft a successful QIDP designation application, what advantages designation offers, and why it’s worth considering specialized support.     [![FDA Regulatory Consulting](https://no-cache.hubspot.com/cta/default/6835044/4f1f3f73-4bc7-4665-83f7-8cba410e4ca3.png)](https://cta-redirect.hubspot.com/cta/redirect/6835044/4f1f3f73-4bc7-4665-83f7-8cba410e4ca3)   ---   #### AUTHOR   ![Teonia Jarrett](https://info.pacelabs.com/hs-fs/hubfs/PLS/SMEs/Teonia%20Jarrett.jpg?width=150&height=152&name=Teonia%20Jarrett.jpg) **Written By:** **Teonia Jarrett**, PharmD, MBA        [![Contact Us](https://no-cache.hubspot.com/cta/default/6835044/98262d2c-8ae1-4867-8da6-84f2b98af8d5.png)](https://cta-redirect.hubspot.com/cta/redirect/6835044/98262d2c-8ae1-4867-8da6-84f2b98af8d5) ### **Get The Whitepaper** ##### ANALYTICAL + ENVIRONMENTAL ANALYTICAL + ENVIRONMENTAL - [Analytical + Environmental](https://www.pacelabs.com/analytical-environmental/) - [Emergency Services](https://www.pacelabs.com/analytical-environmental/emergency-disaster/) - [Statement of Qualifications](https://info.pacelabs.com/hubfs/Statement%20of%20Qualifications/Pace%20SOQ.pdf) ##### LIFE SCIENCES LIFE SCIENCES - [Life Sciences Page](https://www.pacelabs.com/life-sciences.html) - [CDMO/CRO Services](https://www.pacelabs.com/life-sciences/cdmo-cro-services/) - [Central Laboratory Services](https://www.pacelabs.com/life-sciences/central-laboratory-services/) - [Medical Device](https://www.pacelabs.com/life-sciences/medical-device/) ##### PROFESSOINAL SERVICES PROFESSOINAL SERVICES - [Professional Services](https://www.pacelabs.com/professional-services/) - [Regulatory & Compliance](https://www.pacelabs.com/professional-services/regulatory-and-compliance/) - [Scientific Staff](https://www.pacelabs.com/professional-services/scientific-staff/) - [Instrument Services](https://www.pacelabs.com/professional-services/instruments/) - [Facility Qualification](https://www.pacelabs.com/professional-services/facilities/) ##### OTHER OTHER - [Company](https://www.pacelabs.com/company/) - [Careers](https://www.pacelabs.com/careers/) - [Contact](https://www.pacelabs.com/contact-us/) - [Privacy Policy](https://www.pacelabs.com/legal-notice.html) Copyright © 2026 Pace®