In Case You Missed It: Top 10 Gray Sheet Stories In June
This article was originally published in The Gray Sheet
The most popular online stories last month in The Gray Sheet included a "Compliance Corner" piece on nightmare scenarios firms have experienced during facility inspections; a scoop on the new chief of device evaluations at FDA; and our coverage of the dynamic regulatory situation in Europe.
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Device industry veteran John Sheets has been appointed as the new director of FDA's premarket review office for devices. It’s the second time this year that CDRH has tapped an industry executive to lead one of its offices.
AdvaMed's new chief Scott Whitaker says industry doesn't want to sign onto a new "national evaluation system" for devices championed by FDA until it is convinced that the initiative will enhance, rather than hinder, premarket product development.
The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.