Food And Drug Administration, Partner In Drug Development

摘要

The Food and Drug Administration (FDA) serves many masters: the public, the academic and commercial research community, corporate drug developers, sister governmental agencies (National Institutes of Health, Centers for Medicare and Medicaid Services), and the legislative and executive branches of the government. The visibility of their decisions affects many constituencies, and this makes the FDA an easy target for unfair criticism. Their process of regulatory review and approvalrnof new drugs, although a major service, is rarely appreciated. They are an approval agency and must selectively take negative positions and make decisions unfavorable to some petitioners. Over the years, their actions have been seldom praised and blamed often, even though they have demonstrated capability and responsiveness to suggestions.