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FDA updates guide on comms about unapproved use of approved medical products

Image: A sign for the Food And Drug Administration located in Maryland.
Photo: Sarah Silbiger/Getty Images

Final guidance clarifies FDA approach and addresses issues the industry raised regarding a draft version.

Last month, the US Food and Drug Administration (FDA) released its latest guidance, Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers. In this final guidance, the FDA describes recommendations for medical product manufacturers intending to disseminate

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