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At Long Last, FDA Sends Draft Harmonized Quality System Regulation To OMB For Review

 
• By Shawn M. Schmitt

It’s been several years in the making, but the US FDA has finally sent its retooled QSR to the White House Office of Management and Budget for review. The agency has been working on harmonizing its QSR with quality systems standard ISO 13485 since 2018.

popping champagne on black background
• Source: Alamy

The US Food and Drug Administration on 5 January sent a draft of its long-awaited harmonized Quality System Regulation to the White House Office of Management and Budget (OMB) for regulatory review.

The OMB announced on its website the draft rule’s transfer from the FDA. While this is a major step...

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