Citizen Petition Preemption Of FDA Action Barred Under Proposed Rule
This article was originally published in The Tan Sheet
Pending FDA actions cannot be the subject of a citizen petition submitted to the agency under a proposed rule published in the Nov. 30 Federal Register.
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FDA's proposal to ban citizen petitions on pending regulations "appear[s] to preclude the introduction of new data and information in the OTC drug review," the Consumer Healthcare Products Association argues in Feb. 28 comments.
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.