FDA guidances promote greater communication to payors about medical product value, clarify CFL communications

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as “consistent with" FDA-required labeling. FDA Commissioner Scott Gottlieb, M.D., said these guidances aim "to help facilitate contracting for new medical products that are based on the value that these products are delivering to health systems, providers and especially patients."

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