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Dove Medical warning letter rescinded by FDA due to agency filing error.

This article was originally published in The Gray Sheet

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Executive Summary

DOVE MEDICAL WARNING LETTER ISSUED DUE TO FILING ERROR has been rescinded, FDA says in a Nov. 5 letter to the company. The Oct. 29 warning letter cited the firm for not filing an initial product report or annual reports for its OsteoAnalyzer. In the rescission letter, FDA acknowledges that it mistakenly issued the letter because it could not locate files.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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