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FDA May Well Need OTC Drug Funding, But Stakeholders Want Program Specifics

 
• By Malcolm Spicer

The monograph program was "instituted, really, many, many decades ago. We've been trying to implement it since," said CDER Director Janet Woodcock at a recent FDA hearing. While FDA drug leadership was candid in laying out a general case for industry user fees, stakeholders seek detail on how the additional funds would be used, among other specifics.

FDA drug officials pulled few punches at a recent hearing on potential industry user fees for the OTC drug monograph program, recognizing current failings and admitting, frankly, that the agency is struggling to keep up with related science and market developments.

The monograph program was "instituted, really, many, many decades ago. We've been trying to implement it since," said Center for...

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More from Policy & Regulation

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