Final Report of the Advisory Committee on the Food and Drug Administration, May1991

摘要

During a year of public testimony, debate, and deliberation, the AdvisoryCommittee on the Food and Drug Administration (FDA) examined the mission, structure, and responsibilities of the FDA. The mandate was not to micromanage the FDA nor to rectify past errors; rather, it was to help the FDA prepare for the unprecedented challenges it is certain to face in the future. The Committee concludes that the FDA is under great stress and that fundamental changes must be implemented if the Agency is to fulfill its responsibility of protecting the public health effectively, now and in the years to come. They offer a number of recommendations for achieving these fundamental changes. Chief among them are: Defining mission and setting priorities; Enhancing status and increasing authority; Strengthening enforcement capabilities; Improving management; and Augmenting resources.