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CDER Asked To Shed More Light On Potential Monograph User Fees

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Bayer Links OTC User Fees To Exclusivity, Hisamitsu Pans General Concept

Bayer HealthCare encourages FDA to grant periods of market exclusivity to firms charged user fees for monograph proposal, while Hisamitsu America questions FDA's basic rationale for why a fee is needed to improve the monograph system.

Bayer Links OTC User Fees To Exclusivity, Hisamitsu Pans General Concept

Bayer HealthCare encourages FDA to grant periods of market exclusivity to firms charged user fees for monograph proposal, while Hisamitsu America questions FDA's basic rationale for why a fee is needed to improve the monograph system.

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

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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