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Drug name guidances

Executive Summary

FDA is working on three guidances to help avoid medication errors due to drug name confusion. The first addresses policy considerations related to the process of submitting trade names, such as what FDA will and will not accept; another guidance provides general recommendations on labeling and packaging issues, including prominence and total drug content; the third will provide more specifics on the analysis and submission of data for trade name review, including possible studies companies could conduct to evaluate look-alike and sound-alike names

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