Some REMS May Still Require Review Extensions In New Model
FDA’s proposed new review model may cut out the need for some deadline extensions, but if an extensive REMS is expected, the date still could be delayed.
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FDA 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.
FDA wants industry to agree to a set of reasons that would automatically trigger a longer application review as part of the negotiations on reauthorizing the Prescription Drug User Fee Act.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.