FDA and industry just spent more than a year negotiating a MDUFA V reauthorization agreement that is now before Congress. While lawmakers will scrutinize the details of the deal in hearings, which kicked off this week, they are ultimately not going to make any changes to the core agreement. The priority is to pass it well before the September 30 deadline to ensure FDA has the resources it needs. (See “MDUFA V Deal Features Add-On Payments, Hiring Targets, and FDA’s TAP,”Market Pathways, March 10, 2022.)

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