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.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.