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.
Use the search box to filter the chart data. Click on column headers to sort the information.
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
