Fetroja is a new antibiotic to treat complicated urinary tract infections (cUTI). However, we have concerns about the drug because FDA approval was based on two clinical trials that raised questions about safety and effectiveness that were not answered.
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NCHR Testimony on Cefiderocol to Treat CUTI
October 16, 2019. While there is a need for new antibiotics, those products need to have sufficient evidence of efficacy and safety. To continue to be the “gold standard” for approval, FDA needs to maintain high standards of evidence for approval.
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