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US FDA to be stricter on submissions for proprietary name reviews

This article was originally published in SRA

Executive Summary

Companies submitting applications for reviews of their proposed proprietary drug names to the US Food and Drug Administration should expect to see an increase in the number of so-called “incomplete” letters the agency issues in fiscal year 2010. The warning came from Carol Holquist of the FDA’s Center for Drug Evaluation and Research in her presentation at the Drug Information Association’s 45th Annual Meeting in San Diego, US, on 22 June. Karen Finn reports.

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