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.
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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