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

 
• By Derrick Gingery

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....

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