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

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