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For FDA, The Third Time Wasn’t The Charm For Releasing A Draft Of Its Harmonized Quality System Reg

 
• By Shawn M. Schmitt

The US agency missed yet another internal deadline for publishing a draft of its revised Quality System Regulation. The FDA’s April 2020 target for releasing a draft is the third one it failed to meet; it has been working on harmonizing the QSR with ISO 13485 since mid-2018.

Third time is not a charm

The US Food and Drug Administration has missed yet another internal deadline for publishing a draft of its retooled Quality System Regulation. The agency has been working on harmonizing its QSR with international quality systems standard ISO 13485 since mid-2018.

The FDA’s April 2020 deadline for releasing the draft is the third one it failed to meet. The agency had previously set target publish dates of April 2019...

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