US FDA: Twee nieuwe richtsnoeren voor medische producten

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 Persbercht, 12 juni 2018).
Klik hier om het FDA-persbericht over de richtsnoeren te lezen (inclusief downloadlinks).
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