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BioPharmaceutical Medical Device United States

Will Combination Products Join The User Fee Family?

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Executive Summary

Joint drug and device negotiations for combination products, separate performance goals, or maybe a separate pathway have been discussed.

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Combo Products Won't Get Special Review Pathway At US FDA Anytime Soon

Jeffrey Shuren and Janet Woodcock tell Senate committee that agency is more concerned with implementing combination product provisions of the 21st Century Cures Act.

PDUFA First: Fees To Support US FDA Device Center Staff

To enhance combination product reviews, drug-fee revenue will pay for related positions in the agency's Center for Devices and Radiological Health.

FDA's Combo Products Review Transformation Begins

Pilot project sets timelines for lead and consulting centers that will feed into more substantial changes in PDUFA VI.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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