FDA Adds OTC Monograph Staff By Shifting CDER Appropriations
This article was originally published in The Pink Sheet
CDER will add five staff members to expand to 23 the number committed to working on the monograph program, an unexpected development for the OTC industry especially in light of FDA's proposals for monograph program user fee.
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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.
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."
Executives from OTC drug manufacturers list numerous doubts about the equity and effectiveness of a potential program that would impose user fees on firms that make or market monograph drugs, the vast majority of nonprescription pharmaceutical products.