FDA resurrects proposal to gauge quality metrics in pharma manufacturing
The FDA is once again returning to its hotly-contested quality metrics program for pharma manufacturers, even as companies have expressed major reservations.
The agency’s focus on quality metrics began in 2015 and continued with a heavily revised draft guidance (following industry critiques) on how to submit metrics data, including quality-related complaints. Eventually, the guidance spawned two FDA pilot projects in 2018.
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