Califf Supports Combo Products Pathway At Confirmation Hearing
This article was originally published in The Gray Sheet
FDA's concepts for a new pathway could be ready for congressional scrutiny within a year, Deputy Commission Robert Califf said during his confirmation hearing before the Senate HELP Committee. Most committee members expressed support for Califf's nomination to lead FDA, although he fielded some questions on his ties to industry.
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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.
The Senate confirmed Robert Califf as the new FDA commissioner after months of delay, giving the cardiologist, clinical trial expert and established agency official a better platform to push his priorities, which include combination product and clinical data-collection reforms, while implementing projects already under way.
Two more senators, Edward Markey, D-Mass., and Joe Manchin, D-W.Va., announced their opposition to Robert Califf to head the FDA, citing the appointee’s financial ties to industry and weak position on prescription opioid addiction, but the White House said the president stands behind his nominee.