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 GFI: 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.
Approved without change
|New collection (Request for a new OMB Control Number)||2018-06-14|