FDA and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

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A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors -

On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft guidance documents that have been closely watched:

(1) Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers[hereinafter “CFL Guidance”].

The CFL Guidance addresses how the Agency will treat information that is “consistent” with, but not contained in, FDA-required labeling (often referred to as “consistent communications” or “CFL communications”).

Please see full Alert below for more information.

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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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