The Drug Approval Process at the Food and Drug Administration:  New Biotechnology as a Paradigm of a Science-Based Activist Approach

Henry I. Miller, MD; Frank E. Young, MD, PhD
Arch Intern Med. 1989;149(3):655-657. doi:10.1001/archinte.1989.00390030115022.
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There are many stereotypes about bureaucrats. They have given rise, for example, to the quip about the most feared statement in the world, "I'm from the government, and am here to help." Our mail and professional contacts indicate that within the medical community, the mission, procedures, and capabilities of the Food and Drug Administration (FDA) are not well understood. This is especially unfortunate when increasing expectations are being placed on the FDA. Now perhaps more than ever, the FDA needs the active involvement of the medical community in conducting clinical trials, reporting adverse reactions, and educating patients on the availability and use of new therapies. In this article, we will relate how the FDA's recent drug review activities reflect a strong science base and an "activist" philosophy and use new biotechnology products as a paradigm of the agency's approach.

THE FDA'S HISTORY AND MANDATE  The FDA's roots lie deep in


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