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NDMA might support "user fees" for OTC monograph activities -- association's Cope.

This article was originally published in The Tan Sheet

Executive Summary

NDMA WILLING TO CONSIDER "USER FEES" FOR MONOGRAPH ACTIVITIES once again, association President James Cope stressed during discussions with FDAers at the Nonprescription Drug Manufacturers Association annual Research & Scientific Development Conference Nov. 12-13 in Washington, D.C. As part of a dialogue about inadequate appropriated funds for OTC ingredient monograph-related activities, Cope "renew[ed] the pledge" made during 1991 Prescription Drug User Fee Act (PDUFA) negotiations that the trade association would be "willing to discuss" user fees to support OTC drug monograph activities.

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