FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. This client alert provides an overview of the following two documents:

(1) The Final Rule Revising the “Intended Use” Regulations – This final rule was issued on January 9, to clarify, among other things, the meaning of the term “intended use” in connection with FDA’s authority to regulate medical products, see 82 Fed. Reg. 2193 (Jan. 9, 2017); and...

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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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