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ANALYTE SPECIFIC REAGENT LABELING CHANGES DUE BY NOV. 1998 UNDER FDA FINAL RULE; ASR MANUFACTURERS TO BE RESPONSIBLE FOR PREMARKET FILINGS, FDAers SAY

This article was originally published in The Gray Sheet

Executive Summary

Analyte specific reagent manufacturers have until Nov. 23, 1998 to meet labeling and other requirements of the ASR final rule published by FDA Nov. 21. The one-year phase-in gives firms the opportunity to "deplete their current stock of labels," the agency explains.
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