1. Pink Sheet

FDA’s Revised Quality Metrics Program: Voluntary Now, Mandatory Later

 
• By Bowman Cox

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 Meanwhile, a revised draft guidance lays out plans for voluntary quality metrics reporting that could begin by January 2018.

FDA will require quality metrics reporting by rule rather than by guidance, the agency said Nov. 25 in revised draft guidance on its quality metrics program.

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