Podcast: More Data Integrity Guidance From FDA Would Help
This article was originally published in The Gray Sheet
Executive Summary
Cathy Burgess with law firm Alston & Bird spoke on a panel at the Food and Drug Law Institute annual conference about data integrity. In a post-panel chat with “The Gray Sheet,” Burgess says device firms are vulnerable to the same data-integrity issues that drug firms have been called out for in recent FDA enforcement actions. She says more FDA guidance would be useful for both industries.
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