June 15, 2018

Communicating Beyond the Label: FDA Guidance Finalized

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On Wednesday, June 13, 2018, the Food and Drug Administration (FDA) finalized two important guidance documents related to communications about prescription drugs and medical devices. The draft versions of these guidance documents were released in January 2017. These recent finalized versions represent a significant opportunity for marketers of medical products to revisit existing practices and resolve some outstanding questions, especially regarding providing information to payors prior to receiving FDA approval.

In light of these new guidances, Intouch Solutions recommends that prescription drug and medical device manufacturers take a number of actions. To learn more about the finalized guidance documents and how they affect pharma and medical device marketers, download the POV.