examples of evidence-based, computer-aided systems are available to assist with this kind of therapeutic decision making. In the longer term, it would be desirable to develop technology that bridges the gap between diagnosis and treatment by rapidly identifying the infectious agent but also pointing the way to a highly targeted therapeutic agent. However, few orphan drugs that have been developed to treat rare emerging infectious diseases were identified, and the realities of the pharmaceutical industry (and of clinical trials with small populations of patients) militate against the development of narrow-spectrum, low-volume drugs, particularly when the restrictions created by the use of drug formularies are considered. FDA is developing guidelines for off-label use, product marketing information, direct advertising to the consumer, and on the role of pharmaceutical benefits management companies; the effects of these regulations on drug development and drug formularies remain to be determined.

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