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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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.