Companies Need Interactive Web Site Archives: Article

Hanzo compliance product manager Will Walker says FDA-regulated companies need to have fully functional, interactive Web site archives that they can use to prove to FDA that their advertising and promotional content was and is in compliance with regulations. Writing in an online post, Walker says that without an interactive archive, companies may have difficulty responding to an agency violation letter that relies on screenshots that don’t give a full and fair view of an ad.

“Complete, interactive Web site archives should exactly demonstrate what the consumer saw and experienced in a video ad, promotional banner, or product Web site so the company can present the full picture to FDA when needed,” Walker writes.

He suggests ways in which appropriate archives can be developed and uses a violation letter for Amgen’s Neulasta to illustrate “how awkward and stilted it is to describe a smooth, flowing animation using still frame images with text descriptions.”