MDUFA IV Takes Shape: A Catalogue Of Draft Commitments

More specific details have emerged about the agreement "in principle" announced last week by FDA and industry negotiators on the next round of the medical device user-fee program, which will extend from fiscal years 2018 through 2022.

businessman and businesswoman are shaking hands and exchanging folder after agreement was reached

The extra $320.5m (plus inflation) in medical device user fees the US FDA plans to collect during the five fiscal years beginning in 2018 will help fund several completely new review performance goal categories, upgrades to some existing goals, and a range of structural and process enhancements at the agency.

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