OMB Completes Review Of FDA’s Draft Harmonized Quality System Regulation

The White House Office of Management and Budget’s concluded action was “consistent with change,” which means modifications were made to the draft rule during its review.

QSR-ISO_193503416

The White House Office of Management and Budget (OMB) on 8 February completed its regulatory review of the US Food and Drug Administration’s draft harmonized Quality System Regulation.

The OMB finished its review in a swift 35 days. The FDA had sent the draft rule to the office on 5 January after working on it for nearly four years

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