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Apply User Fees To Postmarket Data Collection In MDUFA IV, Pew Argues

In the next round of MDUFA talks, FDA should target some industry user fees at gathering postmarket data, to support FDA’s growing emphasis on relying on postmarket data to resolve premarket uncertainties, Pew says in Aug. 12 comments.

Now that medical device user fees have improved FDA’s premarket approval rate and shortened review times, some fees should go to collection of data in the postmarket setting, Pew Charitable Trusts argues.

“As part of the next iteration of the user fee program, improvements to the postmarket surveillance infrastructure will support effective...

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