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On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft guidance documents that have been closely watched: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