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Antiseptic TFM performance criteria too stringent, industry rep tells FDA advisory cmte.

This article was originally published in The Tan Sheet

Executive Summary

ANTISEPTIC TFM PERFORMANCE CRITERIA TOO STRINGENT, INDUSTRY REP claims at FDA's Nonprescription Drugs Advisory Committee meeting in Bethesda, Md. July 29. Rhonda Jones, Scientific & Regulatory Consultants, Inc., presented to the committee five examples of antiseptic formulations used in consumer and health care environments she said "fall short of the current performance criteria proposed" in FDA's 1994 health care antiseptic tentative final monograph. Two triclosan hand washes at 1% and .3% -- levels of the ingredient often found in consumer products -- do not meet TFM performance criteria, despite having "positive clinical outcomes" and the potential for "viral removal" in other studies, Jones said.
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