Scientific Publications by FDA Staff

Drug Info J 1995 Jan;29(1):11-18

Reinventing Advisory Committee Management at the Food and Drug Administration

Golden MS, Witt A

In 1991, the Institute of Medicine (IOM) began a study of the Food and Drug Administration's (FDA) advisory committee system. The IOM's report, issued in 1992, concluded that the system was fundamentally sound, but recommended a variety of administrative and procedural changes to improve the performance and usefulness of the system. FDA, which had also conducted an internal review of its committee operations, responded to the IOM's recommendations and those of its internal review by developing the recently published ¿Policy and Guidance Handbook for FDA Advisory Committees.¿ The handbook contains over 100 new and revised policies governing advisory committee administration. The new policies, which cover every facet of advisory committee operations from recruitment of new members to conducting meetings, will help improve communications among FDA, its advisory committees, and the public; will strengthen committee independence and integrity; and will both streamline and improve agency accountability for operations of its committees.