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FDA citizen petition tentative replies should indicate agency position, IG says.

This article was originally published in The Tan Sheet

Executive Summary

FDA CITIZEN PETITION TENTATIVE REPLIES SHOULD INDICATE POSITION as to whether the petition will be granted or denied, the HHS Inspector General recommends in a report reviewing the FDA citizen petition process. The report recommends the agency "include in all tentative responses to petitioners an estimate of when a final response will be issued and, to the extent possible, a preliminary indication of whether FDA will approve or deny the petition." The report was issued July 17.
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