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US FDA Opens Next Round Of Quality Metrics Debate With New Menu Of Options

 
• By Bowman Cox

Based on industry feedback from pilot programs, agency proposes for discussion a layered approach to quality metrics reporting that industry sectors and individual manufacturing facilities could tailor to their needs.

Menu of options
now industry can feast on a choice of quality metrics • Source: Alamy

The US Food and Drug Administration is asking industry for feedback on a new, more flexible approach to pharmaceutical quality metrics reporting the agency has developed that reflects lessons learned from two pilot programs.

The agency did not go so far as to propose the new reporting program in a 9 March Federal Register notice. But it provided some background, explained its current...

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