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 or discuss
FDA updates guide on comms about unapproved use of approved medical products
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Final guidance clarifies FDA approach and addresses issues the industry raised regarding a draft version.