In Case You Missed It: Top 10 "Gray Sheet" Stories In December
This article was originally published in The Gray Sheet
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.
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As the number of de novo applications and pre-submission consultations keep growing, FDA is proposing to institute provide new funding for these programs, among a range of additional proposals laid out in a recent closed-door negotiation. The agency's plan aligns somewhat with an industry proposal, according to meeting minutes, but there is also a lot to negotiate.
A patent review board found that a remote monitoring patent owned by a “non-practicing entity” was invalid due to obviousness. So-called "patent troll" cases had been relatively rare in the device arena, but there has been an increase in activity.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.