Up­dat­ed: FDA calls for non­in­fe­ri­or­i­ty tri­als for an­tibac­te­ri­als, thanks to new drugs for re­sis­tant in­fec­tions

The FDA on Mon­day said it up­dat­ed its rec­om­men­da­tions for the clin­i­cal de­vel­op­ment of new an­tibac­te­r­i­al drugs, and thanks to a new clutch of drugs, spon­sors will have to con­duct non­in­fe­ri­or­i­ty tri­als that in­clude sub­jects with in­fec­tions caused by cer­tain drug-re­sis­tant or­gan­isms be­cause an ef­fec­tive ac­tive con­trol can be pro­vid­ed.

The guid­ance, which has since been re­leased, builds on a 2017 doc­u­ment and spec­i­fies what non­in­fe­ri­or­i­ty tri­al de­signs may be used “with a wider NI mar­gin,” in­clud­ing cas­es in which the tri­al pop­u­la­tion is en­riched for sub­jects with in­fec­tions caused by cer­tain drug-re­sis­tant or­gan­isms, FDA said.

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