Validation Center™

In May 2009, the FDA published this draft guidance document for public review and comment. 

This draft guidance describes the factors that the FDA considers when evaluating advertisements (ads) and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices.  Internet web sites promoting these products are also within scope.  The draft guidance discusses factors that are relevant to the disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these factors.

Web site designers and builders will want to review section III.C.2., Non-Print Promotion, for specific design requirements.