Califf Plans US FDA, NIH Collaboration On Postmarket Evidence Generation
NIH Director Nominee Monica Bertagnolli is on board with both agencies working to better determine how approved treatments work in the real-world, FDA Commissioner Robert Califf said.
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FDA Commissioner Robert Califf said pharma should not be the sole entity handling postmarket research.
FDA Commissioner is ‘pretty excited’ about obtaining high quality evidence in the postmarket space, noting agency's collaboration with NIH. He cites need to address the low cost of generic drugs as a factor in drug shortages.
Former NCI Director Monica Bertagnolli, who now is head of the NIH, said FDA, NCI and National Clinical Trials Network officials are working on potential clinical trial system innovations.