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Negotiating Prices For Real-World Data Can Lower FDA Submission Costs, Shuren Says

A new national evaluation system for devices will provide collective bargaining power to reduce the costs of real-world data to substitute for clinical trials in company submissions.

The future "national evaluation system" that FDA envisions for devices can serve as a collective bargaining tool for cheaper access to real-world data to device companies' support of premarket and postmarket requirements, according to FDA Device Chief Jeffrey Shuren.

"Today you might have to have clinical data to get a new use for a device, for postmarket requirements, for...

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