Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees

摘要

This guidance document is intended for FDA staff involved with advisory committee matters, FDA advisory committee members, and the public to help describe the applicable laws, regulations, and policies for determining whether an advisory committee member has a potential conflict of interest and whether participation in an advisory committee meeting is appropriate. FDA plans to develop further staff instructions consistent with this guidance to assist staff in implementing the guidance. This guidance describes FDAs policy in applying the statutory and regulatory requirements found in 18 U.S.C. 208(b), 21 U.S.C. 379d-1, and 5 CFR 2640. This guidance applies to special Government employees (SGEs) and regular Government employees invited to participate in FDA advisory committees subject to the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2). For purposes of the guidance, we refer to such SGEs and regular Government employees as advisory committee 'members'. 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.