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Keeping Track: Incomplete Responses For Unusual Times; Qtrypta Is Latest CRL

Executive Summary

Highlights from complete response letter news from the Pink Sheet’s US FDA Performance Tracker.

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Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.

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