Resources for Food and Drug Administration (FDA)

Draft Guidance for The Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA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

FDA

This guidance document is intended for use by FDA staff involved with advisory committee matters. This guidance document describes the factors and analyses that you should consider in determining whether an advisory committee member has a potential conflict of interest and whether participation is appropriate. This guidance describes FDA's policy in applying the statutory and regulatory requirements found in 18 U.S.C 208(b)(1), 18 U.S.C. 208(b)(3), 21 U.S.C. 355(n)(4), 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."

View the Resource

Share or bookmarklet this web page at: