FDA finalizes QIDP Q&A guidance

Regulatory NewsRegulatory News | 11 May 2021 |  By 

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on its qualified infectious disease product (QIDP) designation program.
The 12-page guidance finalizes a draft version released for comment in 2018 and includes a revised question and answer section providing clarification on the types of products the agency considers to be antibacterial or antifungal drugs for the purposes of the designation. (RELATED: FDA Drafts Q&A Guidance on QIDP Designation, Regulatory Focus 29 January 2018).
The final guidance also includes additional clarification on the timing and content of new requests for QIDP designation.
The QIDP designation was created under the Generating Antibiotic Incentives Now (GAIN) provisions of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). Drugs approved with the QIDP designation are eligible for an additional five-year exclusivity extension on top of any other exclusivity the application qualifies for. Other benefits of the designation include priority review for the first application submitted for approval for a QIDP and are eligible for fast-track designation upon the sponsor’s request.
“For the purpose of QIDP designation, FDA generally intends to consider a drug product to be an antibacterial or antifungal drug intended to treat serious of life-threatening infections if the sponsor can provide information to show that the drug product directly inhibits replication of, or kills, bacteria or fungi relevant to the proposed indication at concentrations that are likely to be attainable in humans to achieve the intended therapeutic effect,” FDA explains. Products that are infeasible to study in human subjects due to anticipated toxicity will not be considered for the designation.
The guidance addresses a total of 14 questions related to the QIDP designation, including questions on the procedures involved obtaining the designation and its incentives, GAIN exclusivity and information related to qualifying pathogens.
FDA notes that products do not have to be intended to treat an infection caused by a qualifying pathogen to be eligible for QIDP designation, as the list of qualifying pathogens established under GAIN operates under a different set of criteria.
FDA, Federal Register Notice


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