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CDER Asked To Shed More Light On Potential Monograph User Fees

 
• By Malcolm Spicer

While Director Janet Woodcock and other CDER officials explain the center's reasons for proposing a monograph program user fee, some stakeholders suggest the agency explain more about how the program would work.

Most drug industry stakeholders agree that FDA needs additional funding to regulate the OTC sector and make more self-care products available, but some need convincing the agency is on the right track looking at a potential user fee for the OTC monograph program.

At a June 10 public meeting, Center for Drug Evaluation and Research Director Janet Woodcock and other officials explained the...

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