QIDP Roundup: Familiar Names Dominate 2019 Designations

US FDA's Qualified Infectious Disease Product program is growing slowly, but still growing.

Antibiotic-resistant-bacteria

The US Food and Drug Administration’s Qualified Infectious Disease Product (QIDP) designation program is growing slowly, but it is growing, as 2019 has seen a rash of new designations in new indications for QIDP status for Iterum Therapeutics PLC’s penem antibiotic sulopenem and Polyphor Ltd.’s Pseudomonas-targeting murepavadin, as well as a QIDP for a third candidate from Spero Therapeutics Inc..

The QIDP designation count for Iterum’s sulopenem reached seven, thanks to new designations for community-acquired bacterial pneumonia (CABP), acute bacterial...

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