FDA’s Revised Quality Metrics Program: Voluntary Now, Mandatory Later
US FDA will establish mandatory quality metrics reporting through a formal rulemaking process that could take years. Meanwhile, a revised draft guidance lays out plans for voluntary quality metrics reporting that could begin by January 2018.
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Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.
US FDA Opens Next Round Of Quality Metrics Debate With New Menu Of Options
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Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
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