Qualified Infectious Disease Product Designation Questions and Answers; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Qualified Infectious Disease Product Designation Questions and Answers.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) creates incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this draft guidance is to provide a resource for information on FDA's policies and procedures related to the designation of a qualified infectious disease product (QIDP).