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Public Invited To Vet Draft User-Fee Agreement At Nov. 2 Meeting

The public will have a chance to discuss the tentative deal US FDA struck with industry to collect almost $1bn over five years in the next iteration of the device user-fee program at a statutorily-mandated meeting scheduled for Nov. 2.

Industry and public representatives alike can sign up to participate in an open meeting early next month at US FDA headquarters to talk about the fourth device user-fee deal recently struck with the agency.

FDA and industry trade groups announced that a draft MDUFA IV agreement was reached in August. The agreement includes some new review performance goal categories, upgrades to some existing goals,...

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