FDA’s Proposed Name Review Pilot Offers Little Reason To Participate
This article was originally published in The Tan Sheet
Executive Summary
A proposed FDA pilot program that would shift the burden for safety review of proprietary drug names from the agency to industry needs to account for key differences between OTC and Rx products and lacks participation incentives, pharmaceutical researchers say
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FDA issues naming guidance
A guidance published Feb. 8 outlines what information FDA needs from manufacturers to evaluate proposed proprietary names to ensure the names do not look or sound like other drug names, which could cause medication errors, according to a Federal Register notice. The 1guidance does not include long-awaited best practices for naming, labeling and packaging drugs or details on a pilot program for evaluating proposed proprietary names, according to the notice. FDA's pilot program to reduce drug name confusion offered firms little reason to participate (2"The Tan Sheet" June 30, 2008). The drug name review process does not apply to monograph drugs but to Rx drugs and OTCs approved through new drug applications, abbreviated NDAs and investigational new drugs