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FDA Releases Long-Awaited Off-Label Guidance

Posted in FDA, Life Sciences, Medical Devices, Pharmaceuticals

On June 12, the U.S. Food and Drug Administration (FDA) published two new guidance documents that address how companies can share off-label information with insurers and healthcare professionals about drugs and medical devices, as well as information for uses that haven’t yet been approved.One guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers,” addresses how drug and medical device companies can share economic and other information about drugs and medical devices with insurance companies and other payors. The other, “Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers,” addresses how companies can communicate to healthcare professionals and others information that is not contained in a product’s labeling, but is still consistent with the labeling. This information may include data from post-market studies and surveillance of a product’s approved uses; additional information from the pre-market studies that were used to support approval of the product, including what uses haven’t yet been approved by the FDA; and scientific studies, including studies comparing the safety and efficacy of one drug to another.

The past three month of FDA guidance documents can be found on the FDA’s website.

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