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At US FDA, Adding ‘Effective’ Staff For Overhauled OTC Monograph Program ‘Really Takes Time’

Executive Summary

CDER’s Office of Nonprescription Drugs is “hitting the deck running’” hiring and training staff following passage of OTC monograph reform with user fees to support adding staff and a reshuffling earlier in 2020, says Peter Stein, Office of New Drugs director.

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