Abstract
For the past decade, one of the most active areas in drug development has been the introduction of new anti- infective drug products. Determination of safety and efficacy by the Food and Drug Administration are guided by the General Considerations for the Clinical Evaluation of Drugs and the Guidelines for the Clinical Evaluation of Anti-Infective Drugs. Both were published in 1977. The Infectious Diseases Society of America has negotiated a contract with the FDA to update the existing anti-infective drug guidelines. Additional goals of this project are to develop new disease- and drug-specific guidelines consistent with the current state of the art and science of medicine, consider and provide guidance in areas of controversy in the field of infectious diseases, and present the FDA with a document to guide development of new anti-infective drug products. If successful, this project can serve as a model for future interactions between regulatory agencies and academic societies which have a unique capability to rapidly develop a consensus among leading experts on an issue such as drug development.
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