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

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.

A user fee program included in long-awaited reform of the US Food and Drug Administration’s OTC monograph system will support adding drug center staff but the new funding source isn't a reason for accelerating the hiring and training process.

Leaders at the Center for Drug Evaluation and Research’s Office of Nonprescription Drugs (ONDP) “have been highly motivated to bring...