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Drug Name Review Pilot Tailors Requirements For OTC Participants

This article was originally published in The Tan Sheet

Executive Summary

OTC drug manufacturers participating in FDA's trade name pilot will be required to include consumers in their simulation safety studies and review entire labels, not only product names

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Drug name review software loaded

FDA makes its Phonetic Orthographic Computer Analysis software program available for firms to check if a proposed new drug name looks or sounds like other product names or medical terminology, the agency says in a Feb. 17 Federal Register notice. The agency uses the software to identify look-alike or sound-alike drug names that could cause health care providers or patients to prescribe or use the wrong drug and cause an adverse event (1"The Tan Sheet" Oct. 27, 2008, p. 8)

Drug name review software loaded

FDA makes its Phonetic Orthographic Computer Analysis software program available for firms to check if a proposed new drug name looks or sounds like other product names or medical terminology, the agency says in a Feb. 17 Federal Register notice. The agency uses the software to identify look-alike or sound-alike drug names that could cause health care providers or patients to prescribe or use the wrong drug and cause an adverse event (1"The Tan Sheet" Oct. 27, 2008, p. 8)

Drug name review software loaded

FDA makes its Phonetic Orthographic Computer Analysis software program available for firms to check if a proposed new drug name looks or sounds like other product names or medical terminology, the agency says in a Feb. 17 Federal Register notice. The agency uses the software to identify look-alike or sound-alike drug names that could cause health care providers or patients to prescribe or use the wrong drug and cause an adverse event (1"The Tan Sheet" Oct. 27, 2008, p. 8)

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