PDUFA Negotiations: FDA Wants To Be Able To Call "Time-Out" During Reviews
Executive SummaryFDA has proposed a new application review model that would allow it to call a time-out, which could be used to resolve mid-cycle issues and, the agency argues, potentially bring more predictability to the process.
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NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.