GDUFA Transparency and Inspection Metrics
From teleconferences with sponsors to GMP surveillance activities, FDA touts its user fee accomplishments.
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The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.
With the meetings available on television, access can be assured for just about everyone, and the US FDA can avoid another gut punch to its credibility.
But most generic sponsors already give reasons for needing more time to respond to a complete response letters, so the status quo may not change despite the new guidance.