Drug Regulators, FDA, Publish Guidance for Public, FDA Advisory Committee Members and FDA Staff, on Public Availability of Advisory Committee Members Financial Interest Information and Waivers.
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This guidance is intended to help the public, Food and Drug Administration (FDA) advisory committee members, and FDA staff to understand and implement statutory requirements and FDA policy regarding public availability of information about financial interests and waivers granted by FDA to permit individuals to participate in advisory committee meetings subject to the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2). This guidance describes the basis and provides a format for public disclosure of certain financial interests by special Government employees (SGEs) and regular Government employees participating in these advisory committee meetings, and provides a format for FDA waivers allowing participation in these meetings. This guidance also explains how and when these documents will be made publicly available by FDA.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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