Preparing for FDA Advisory Committee Presentations: Perspective of an Advisory Committee Member *

Abstract

Advisory committees play an important role in the interactions that occur between the pharmaceutical industry and the Food and Drug Administration (FDA). This article highlights the time points at which advisory committee meetings are typically held—end of Phase I and end of Phase II; prior to New Drug Application (NDA) submission; and following FDA review of an NDA—and the type of discussions held at each meeting. The role of advisory committees, and the presentations made by the sponsor and the FDA at advisory committee meetings, are explained. Each advisory committee member must satisfy him/herself that the proposed new drug is safe and effective before recommending that it be approved by FDA.