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

FDA's Jeffrey Shuren and Janet Woodcock tell a Senate committee that the agency is more concerned with implementing combination product provisions from the 21st Century Cures Act than working on a novel review pathway for device/drug combination products.

Shifting priorities at FDA means work on a specific review pathway for combination products has been superseded by implementation of the combo products provision in the 21st Century Cures Act, agency center directors said at a recent hearing in the Senate.

Testifying before the Senate Health, Education, Labor and Pensions (HELP) Committee on March 21, Device Center Director Jeffrey Shuren told Sen. Sheldon Whitehouse, D-R.I., that while FDA is "always open...

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