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In Case You Missed It: Top 10 "Gray Sheet" Stories In June

This article was originally published in The Gray Sheet

Executive Summary

"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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Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say

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.

Roche's Oncology Drug Strategy Emphasizes Comprehensive Diagnostics

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.

Podcast: FDA's Califf Talks About Combo Product Reform, Commish Prospects

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.

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