US FDA: Two guidance documents regarding medical products
The US FDA has issued updated, final guidance documents regarding medical product communications. The first guidance, “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers,” answers common questions about companies’ communications to payors, including insurance companies and similar entities.
The second guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling,” provides the FDA’s views on manufacturers’ communication of information that is not contained in the FDA-required labeling for their products, but that is consistent with that labeling (FDA Press Announcement, 12 June 2018).
Click here to read the FDA press announcement about the guidance documents (includes download links).
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