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CDER Talks Switches, Monograph 'More Than Ever,' But Mum On Changes

This article was originally published in The Tan Sheet

Executive Summary

Officials from FDA's drug center describe their work on the Nonprescription Safe Use Regulatory Expansion initiative and on the center's evaluation of potential solutions to the OTC drug monograph process logjam. A CDER attorneys says FDA" is working towards finalizing" an NSURE regulatory framework.


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