In Case You Missed It: Top 10 "Gray Sheet" Stories In June
This article was originally published in The Gray Sheet
"The Gray Sheet" offerings that captured the most Web traffic last month centered on device recall trends, combination products, exclusive interviews with two FDA officials and our new Device Week podcast.
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Top FDA officials, including CDRH Director Jeffrey Shuren and FDA Deputy Commissioner Robert Califf, are sending strong signals that the designation and review processes for combination products are due for a significant reassessment. That should be a priority topic of upcoming user fee negotiations with industry, they say.
Executives emphasized the role of "comprehensive diagnostics" in its plan to establish a dominant position in immuno-oncology drugs at this years' American Society of Clinical Oncology annual meeting.
In an exclusive interview with "The Gray Sheet," FDA's Deputy Commissioner Robert Califf spoke about concerns the agency has with regulating combination products, provides tips for companies looking to get combo products to market and whether he'd consider taking on the role of FDA commissioner. Listen to our exclusive podcast or read the Q&A transcript.