In Case You Missed It: Top 10 "Gray Sheet" Stories In December
This article was originally published in The Gray Sheet
Executive Summary
Our most popular stories in December included an in-depth exploration of best practices in setting up an effective "war room" during an FDA inspection; a detailed look at user-fee reauthorization proposals early in the negotiation process; updates from the agency's Office of Regulatory Affairs, Office of Compliance, and Office of Device Evaluation; and more.