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Drug name review

Executive Summary

FDA drug name review should be based on data collected from sponsors, rather than from internal agency tests, HHS Advisory Committee on Regulatory Reform recommends during Sept. 9 teleconference. FDA is developing three guidances to help avoid medication errors caused by drug name confusion: to define policy on submitting trade names; provide labeling recommendations; and provide specifics on analysis and submission of data for review (1"The Pink Sheet" Sept. 10, 2001, p. 32)...

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