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(Circulation. 2005;111:1697-1702.)
© 2005 American Heart Association, Inc.

Special Report

The US Food and Drug Administration Cardiorenal Advisory Panel and the Drug Approval Process

Dan M. Roden, MD; Robert Temple, MD

From the Division of Clinical Pharmacology, Departments of Medicine and Pharmacology, Vanderbilt University School of Medicine (D.M.R.), and the Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration (R.T.).

Correspondence to Dan M. Roden, MD, Professor of Medicine and Pharmacology, Director, Division of Clinical Pharmacology, Vanderbilt University School of Medicine, 532 Medical Research Bldg I, Nashville, TN 37232. E-mail dan.roden@vanderbilt.edu

Key Words: US Food and Drug Administration • drugs, cardiovascular • drug approval • risk factors • trials

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
New chemical entities developed by the pharmaceutical industry as potentially useful drugs undergo extensive preclinical evaluation followed by clinical trials to evaluate efficacy and safety in human subjects. In the United States, the Food and Drug Administration (FDA) is charged with evaluating requests from pharmaceutical sponsors for approval to market new drugs or to expand indications for marketed drugs. Some of these decisions are relatively straightforward. Thus, a new drug that shows clear efficacy and little actual or theoretical risk for serious adverse effects and that represents a significant addition to the therapeutic armamentarium does not present a major problem for FDA regulators. Conversely, approval will not be granted for a new drug the efficacy of which cannot be demonstrated, a drug with serious adverse effects that are not shared by alternative treatments, and a drug that does not add importantly to available treatment in at least some patients. In many cases, however, efficacy may not be so clear-cut, risks may be (or may appear to be) more than minimal, and the pharmaceutical sponsor and the FDA may differ in their evaluation of each of these issues. In such cases, the FDA through its Center for Drug Evaluation and Research (CDER) has since 1972 been able to call on panels of experts to provide advice. For cardiovascular drugs, this advice is offered by the Cardiovascular and Renal Drugs Advisory Committee (CRAC). The goal of this article is to summarize how the deliberations of this committee have affected not only individual . . . [Full Text of this Article]

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