USA – FDA finalizes QIDP Q&A guidance

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 DesignationRegulatory Focus 29 January 2018).
 
The final guidance also includes additional clarification on the timing and content of new requests for QIDP designation…