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'Real Challenge' To Improve OTC Monograph Program Without User Fees – FDA

 
• By Malcolm Spicer

FDA looks at the potential benefits and detriments from establishing user fees for the monograph program, opening a docket for comments in addition to conducting the public meeting, as it also considers comments to a docket launched in February 2014 on overhauling the OTC monograph process.

Regardless of the input it receives from OTC drug industry stakeholders and other sources about establishing user fees for the monograph program, FDA knows the program needs more funding to correctly function.

"The FDA does want to see changes to the way that the monograph regulation works to make it a lot more efficient and streamlined," said Karen Mahoney, deputy director of...

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