FDA's Kopcha Presses Ahead On Quality Metrics Despite Industry Pushback
The head of US FDA's drug quality office, Michael Kopcha, rebukes industry pushback that got White House's ear and demands more constructive feedback on quality metrics. Industry workshop participants come up with creative ideas, but FDA finds them problematic. Asked whether industry should dive in or wait and see on voluntary phase of metrics initiative that begins in January, another FDA official says, "That's a tough one."
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