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FDA advisory opinions and guidelines

Executive Summary

Cannot "be construed to bind FDA legally to a particular course of action" and FDA subsequently "can initiate regulatory action when consistent with applicable statutes and regulations," agency says in a proposed rule published in the Oct. 15 Federal Register. The clarification responds to a small number of court cases alleging that the advisory opinion and informal guidelines procedures appear to bind the agency to certain actions in conflict with the "general principle that the government may not be estopped" from enforcing other applicable statutes. FDA also is concerned about whether a purported obligation to follow the opinions and guidelines "may place inappropriate restrictions on FDA's ability to respond to specific situations in ways that best carry out its statutory responsibilities." Nonetheless, advisory opinions and guidelines continue to be "a reliable indication of the agency's expectations" and any "uncertainty resulting from the proposed revision should be minimal," FDA says. The revision does not affect final orders such as those issued through formal rule- making.

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