Risk Information in Prescription Drug & Medical Device Ads, Promotional Labeling – What the FDA Expects

• By: Staff Editor
• Date: November 18, 2011

The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.

This article gives an overview and summary of the recommendations included in the FDA guidance.