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

This article was originally published in The Rose Sheet

Executive Summary

FDA CITIZEN PETITION TENTATIVE REPLIES SHOULD INDICATE AGENCY POSITION on whether the request 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 recommendation is one of seven proposed by the IG to improve the citizen petition process and reduce backlog. The IG's investigation began in July 1997. The report was issued July 17.

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