FDA Updates Guidance Addressing Distribution of Scientific and Medical Publications on Unapproved New Uses

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On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.”  The draft guidance, which sets forth principles consistent with previous agency pronouncements regarding the dissemination of off-label information, updates a guidance released in January 2009 to add recommendations pertaining to the dissemination of clinical practice guidelines that include references to off-label use of a manufacturer’s product(s).  This On the Subject provides a high-level overview of the new draft guidance.

 

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