The purpose of this funding opportunity announcement (FOA)is to support research to develop and qualify a Patient Reported Outcome (PRO)for Non-Cystic Fibrosis Bronchiectasis (NCFB) under FDA’s Drug DevelopmentTools Qualification Program.
This would include the qualitative phase ofdeveloping
the instrument, quantitative phase of testing the instrument, andqualification of the instrument.
It is expected that thisqualified PRO would help improve upon the current design, conduct, andinterpretation of anti-infective clinical trials in NCFB patients, for whichoptimal endpoints are currently lacking.
This work directly aligns with FDA’sresearch area of interest to “stimulate innovation in clinical evaluations andpersonalized medicine to improve product performance and patient outcomes.