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FDA Misses Fifth Target Date For Issuing Draft Harmonized Quality System Reg

 
• By Shawn M. Schmitt

It’s yet another internal deadline missed by the US agency in publishing a draft of its overhauled Quality System Regulation, which is being harmonized with international quality systems standard ISO 13485.

Missing the target concept as a dart way off the mark.
FDA misses another internal deadline for releasing its retooled QSR

The US Food and Drug Administration has failed to meet yet another internal deadline for publishing a draft of its overhauled Quality System Regulation. The agency has been harmonizing its QSR with international quality systems standard ISO 13485 for nearly three years now.

The FDA’s February 2021 target for releasing the draft, set by the agency in December, is the fifth it has missed. The agency previously set deadlines of April 2019, September 2019, April 2020 and

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