FDA rejects Nabriva a second time; Nabriva pins it on travel restrictions
A little over a year after the FDA issued Nabriva its first CRL for the antibiotic Contepo, the agency has issued another.
By Nabriva’s account, the agency’s reasoning hasn’t changed. They again cited unresolved manufacturing issues at the company’s CMO facilities in Europe and asked for no new clinical data. The problem, Nabriva said, was that because of travel restrictions, the agency wasn’t able to do an onsite inspection of the facilities to confirm that the issues raised last year had been fixed.
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