It’s been a long 14 months since the US Food and Drug Administration released a draft Quality Management System Regulation (QMSR) in February 2022, and the wait is not over quite yet.
Medcon 2023: FDA Hopes To Release Final QMSR By Year’s End
The destination may be in sight for the long trip that’s been the US agency’s quality systems rewrite. Regulators speaking at Medcon 2023 said December remains the goal for publication.
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