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All Roads For OTC Policy Improvements Lead To User Fees, FDA Suggests

 
• By Malcolm Spicer

During update on user fee discussions with industry to support FDA's OTC monograph program work, CDER officials say "industry and public would suffer" absent new fees.

All roads lead to user fees as far as improving FDA's process for adding ingredients or indications to OTC drug monographs, Center for Drug Evaluation and Research officials' comments to industry stakeholders suggest.

"There's simply not enough appropriated money to go around for all of the things the agency has to do," said Donal Parks, director of CDER's Division of User Fee Management and Budget Formulation, during a Sept

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