PDUFA VII: Human Factors Review, Finance Flexibility, REMS, And Manufacturing Get Attention

User fee reauthorization negotiators from US FDA and industry divide into subgroups to tackle specific issues before moving to the broader agreement.

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Multiple subgroups are negotiating a range of issues that could be included in the PDUFA VII reauthorization. • Source: Shutterstock

Assessment goals for human factors protocols could be extended as part of the US FDA’s prescription drug user fee reauthorization to account for increasing workload just as a new assessment goal could be created for user-related risk analysis.

FDA officials pitched the human factors assessment goal change during a PDUFA VII pre-market subgroup virtual meeting on 30 September. Minutes indicate that the agency said the current goal...

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