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QIDP Designations

Qualified Infectious Disease Product Designations granted by FDA. Updated upon new designations.

The Qualified Infectious Disease Product Designation was introduced in 2012 as part of the Generating Antibiotic Incentives Now (GAIN) provisions in the FDA Safety and Innovation Act (PDUFA V). It provides incentives such as eligibility for fast track and priority review, as well as an additional five years of exclusivity to be added to other exclusivities, such as orphan designation. It embraces treatments for diseases caused by antibacterial- or antifungal-resistant pathogens, including new or emerging pathogens or diseases. To be considered, sponsors must provide clinical evidence the antibiotic/antifungal can treat the specified pathogen in a specific indication.

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