Antibiotic resistance gets discussed daily and globally. FDA recently convened a meeting to explore non-traditional therapies for bacterial infections (NNTBI). For the time being, no guidelines for the clinical development of NNTBIs are expected to be released. Beyond the challenge of defining NNTBIs, these diverse therapies challenge current models for biomarkers, safety, primary/secondary endpoints and clinical trials.
Sourced: Linked In, September 18, 2018. Link.
. . . regulatory agencies should consider incentivizing companies for the development of new therapies for bacterial infections, with at least the same supports that those given to antibiotics.
INSIGHTS: You can view the agenda, presentations and webcasts here. (https://www.fda.gov/Drugs/NewsEvents/ucm606052.htm)