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Another Delay On The Way? FDA’s Shuren Says Industry Should ‘Anticipate’ QSR Harmonization To Take ‘Little While Longer’

Agency’s device center director plays coy when asked if FDA will keep “Quality System Regulation” name

 
• By Shawn M. Schmitt

Jeff Shuren, director of the US FDA’s device center, signaled on 15 September that the agency might not have the hotly anticipated draft of its retooled Quality System Regulation ready for release by next month.

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The director of the US Food and Drug Administration’s device center signaled on 15 September that the agency might not have the hotly anticipated draft of its harmonized Quality System Regulation ready for release by next month.

The revised rule “remains a high priority for the center, but as you can imagine, with all the attention we’ve had … on COVID-19, there are many other activities we...

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