All Roads For OTC Policy Improvements Lead To User Fees, FDA Suggests
This article was originally published in The Pink Sheet
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.
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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."
Committee members' current priorities do not include authorizing user fee programs for the OTC monograph process or supplement GMP inspections, but proposals could get traction. "We think it is a happy medium of getting FDA the resources it needs," says Tiffany Guarascio, minority chief of staff.