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Too Slow, Too Fast, Or Just Right? Experts Weigh In On OMB’s 35-Day Review Of FDA’s Draft QSR

 
• By Shawn M. Schmitt

Did the White House Office of Management and Budget review the US FDA’s draft harmonized Quality System Regulation too quickly to be thorough? Some industry experts say yes, while others are more optimistic.

An illustration of Goldilocks looking frightened and escaping from the three bears.
• Source: Alamy

When the White House Office of Management and Budget (OMB) sent the draft harmonized Quality System Regulation back to the US Food and Drug Administration on 8 February after only 35 days of review, it raised some eyebrows in industry.

After all, the OMB has, under 1993’s Executive Order No. 12866, 90 days to complete a regulatory review. So why did it take only a smidge more than a...

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