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Device Week, 15 February 2022 – OMB’s Swift Review Of FDA’s Draft QSR

Executive Summary

When the White House Office of Management and Budget, or OMB, sent the US FDA’s draft harmonized Quality System Regulation back to the agency after only 35 days of review, it raised some eyebrows in industry. Check out what experts are saying about the reg review time frame in this week’s podcast.

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