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Regulation of "fast" onset claim for drugs outside FDA purview, NDMA maintains.

This article was originally published in The Tan Sheet

Executive Summary

DRUG "FAST" ONSET DEFINED AS ASPECT OF EFFICACY BY FDA's WEINTRAUB at a meeting of the agency's Arthritis Advisory Committee in Gaithersburg, Md. March 25. In a discussion of fast onset of action claims for prescription and OTC analgesics, Office of Drug Evaluation V Director Michael Weintraub, MD, said, "I believe that `fast' is an aspect of efficacy: the onset of pain relief, in this case, or bronchodilation, or whatever." The meeting also included members of the Nonprescription Drugs Advisory Committee.
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