Keeping Track: Incomplete Responses For Unusual Times; Qtrypta Is Latest CRL
Highlights from complete response letter news from the Pink Sheet’s US FDA Performance Tracker.
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Compliance experts see possibilities in offering video tours as the FDA offers “holistic” approach to assessing sites during pandemic.
If agency has concerns about facilities it cannot inspect, it will generally issue complete responses, Q&A guidance says.
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.