Will Combination Products Join The User Fee Family?
Joint drug and device negotiations for combination products, separate performance goals, or maybe a separate pathway have been discussed.
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Jeffrey Shuren and Janet Woodcock tell Senate committee that agency is more concerned with implementing combination product provisions of the 21st Century Cures Act.
To enhance combination product reviews, drug-fee revenue will pay for related positions in the agency's Center for Devices and Radiological Health.
Pilot project sets timelines for lead and consulting centers that will feed into more substantial changes in PDUFA VI.