Medical Product Communications That Are Consistent With the Food and Drug Administration Required Labeling -Questions and Answers

This information collection supports agency guidance. The guidance provides third-party disclosure recommendations firms should include in their drug and device labeling and prescription drug and restricted device advertising that contain information not found in the FDA-required labeling for their medical products but that are “consistent with the FDA-required labeling” (as that term is explained in the guidance) if they choose to publicly disseminate such materials.

The latest form for Medical Product Communications That Are Consistent With the Food and Drug Administration Required Labeling -Questions and Answers expires 2021-08-31 and can be found here.