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Conflict of Interest

Complete Document

The FDA Waiver Criteria 2000 provides information on how the Agency manages conflict of interest issues related to special government employees (SGE) who serve as advisory committee members, consultants or experts to the Agency. FDA's conflict of interest program has been referred to as a model for other Executive Branch agencies to follow.

The FDA Waiver Criteria 2000 is a guidance document reflecting the Agency's current thinking. The criteria within this document do not translate to rigid decisions and each situation is evaluated within the context of myriad factors presented.

The section titled "Policies and Procedures for Handling Conflicts of Interest with FDA Advisory Committee Members, Consultants and Experts" provides background information on federal conflict of interest statutes and regulations and describes the process FDA follows when a waiver for conflict of interest is sought.

The Waiver Criteria Document:

• describes the kinds of waivers that FDA uses
• defines terms and concepts used in the Conflict of Interest guidance tables
• presents the Conflict of Interest guidance tables
• contains appendices with sample waivers and waiver checklists, appearance determinations and additional requirements under the Food and Drug Modernization Act (FDAMA) for FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research

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