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

 
• By Malcolm Spicer

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.

FDA assures the drug industry that improving its processes for making more ingredients available OTC is important, but the agency is not ready to say when changes will happen.

Officials from FDA's Center for Drug Evaluation and Research speaking at a Consumer Healthcare Products Association conference in Rockville, Md.,...

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