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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FDA Taps New Office of Device Evaluation Director From Industry
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.
Industry Urges Caution In Response To Growing Push For 'Real-World' Device Evaluation System
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.
Big Pharma CEOs Suggest Policy Changes As They Return To Beijing
Global CEOs of J&J, Pfizer, AbbVie and Takeda were among the top pharma executives attending the China Development Forum in its first in-person meeting in three years, and highlighted a number of pharma-related policy changes they would like to see in China. Meanwhile, a Japanese employee of Astellas has been detained in the country for alleged espionage.