Updated FDA Reg Agenda Says New QSR Will Come This Month – But There’s Cause For Skepticism

The US FDA has indicated that it intends to release a draft of its harmonized Quality System Regulation by the end of the year. But time is running out, and the agency has scheduled the draft’s release six other times since 2019.

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The US Food and Drug Administration has updated its official regulatory agenda to indicate that it will release a draft of its new harmonized Quality System Regulation sometime this month.

But time is running out – it’s already 22 December – and the FDA has scheduled the draft’s release six...

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