QIDP Designations

The qualified infectious disease product (QIDP) 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 antibacterials and antifungals that treat serious infections, including drug-resistant pathogens. Sponsors must provide clinical evidence the candidate can treat the specified pathogen in a specific indication. Updated weekly.