In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

Hogan Lovells
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Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents. First, it defines more broadly acceptable claims and evidentiary support for certain forms of promotion and effectively narrows the scope of its past enforcement positions. Second, the Agency simultaneously asserts that strong public health and policy reasons support its long-held position that promotion of an unapproved use of an approved product should remain prohibited.

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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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