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On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.”  The draft guidance, which sets forth principles consistent with previous agency pronouncements regarding the dissemination of off-label information, updates a guidance released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  This On the Subject provides a high-level overview of the new draft guidance.

 

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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