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

Executive Summary

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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Second Wind For OTC Monograph User Fee Legislation In House Hearing

House Health Subcommittee's “Modernizing FDA’s Regulation of Over-the-Counter Drugs” hearing Sept. 13 will "examine draft legislation to establish" a user fee program to support FDA's work on evaluating proposals for additions or changes to its nonprescription drug monographs.

OTC Monograph Reform, User Fee Legislation Coming 'Any Day' – CHPA

Imminent OTC monograph reform legislation signals an agreement between industry and FDA on details of a proposal, which also includes a potential user fee program. CHPA also is hopeful for legislation restoring direct OTC drug purchases with pre-tax savings accounts.

OTC Monograph Reform, User Fee Legislation Coming 'Any Day' – CHPA

Imminent OTC monograph reform legislation signals an agreement between industry and FDA on details of a proposal, which also includes a potential user fee program. CHPA also is hopeful for legislation restoring direct OTC drug purchases with pre-tax savings accounts.

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