OTC Monograph User Fees: FDA-Industry Talks Move From Basics To Details
This article was originally published in The Pink Sheet
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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Several facility fees will increase next year as application fees drop.
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.