FDA Issues Draft Guidance on Presenting Risk Information in Prescription

Recently, the Food and Drug Administration issued a Draft Guidance, “Presenting Risk Information in Prescription Drug and Medical Device Promotion,” that describes factors FDA intends to consider when evaluating risk information for advertisements and promotional labeling of prescription drugs, restricted medical devices, and promotional labeling for all medical devices. The Draft Guidance provides the industry with recommendations on how to comply with the Federal Food, Drug, and Cosmetic Act (“FDCA”) and FDA’s implementing regulations, as well as advises companies to use a balanced approach in presenting the benefits and the risks of a particular product. A copy of the document can be accessed here.


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