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FDA Unveils Guidance On Sharing Info On Unapproved Uses

Law360 (June 12, 2018, 5:21 PM EDT) -- The U.S. Food and Drug Administration on Tuesday unveiled final guidance outlining its recommendations on how companies can share information with insurers about drugs and medical devices that’s not included in the labels, as well as information for uses that haven't yet been approved.

The FDA released two pieces of guidance, including one regarding how drug and medical device companies can share economic and other information about drugs and medical devices with insurance companies and other payors. The guidance is aimed at lowering drug prices by...
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