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Comments on the FDA’s Draft Guidance on Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees

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Public Citizen and seven other groups expressed serious concerns that the proposed guidance would encourage the Food and Drug Administration (FDA) to continue inappropriately excluding advisory committee members from participating in committee meetings based on an “intellectual bias” — a phrase that does not appear in the draft guidance but that the FDA now routinely uses when screening individual advisory committee members for conflicts of interest prior to committee meetings.