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OTC Monograph User Fees: FDA-Industry Talks Move From Basics To Details

 
• By Malcolm Spicer

CDER officials and industry met in July to discuss "the ground rules governing the OTC monograph user fee." CHPA CEO Scott Melville cautions: "No one is going to rush into an agreement that we're going to have to live with for decades."

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FDA and drug firms marketing OTC products have held a series of recent meetings to outline how they will approach discussions on creating user fees for the monograph program, and soon will begin more formal negotiations on the topic.

While participants are reserving commitment on the user fee concept for now, they have laid the groundwork for a process that eventually could lead to asking Congress to authorize user fees to support the OTC

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