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All Roads For OTC Policy Improvements Lead To User Fees, FDA Suggests

Executive Summary

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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Second Wind For OTC Monograph User Fees Legislation In House Hearing

US 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.

Second Wind For OTC Monograph User Fees Legislation In House Hearing

US 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 User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

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