Department of Health and Human Serivces 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public workshop, co-sponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in the development of molecular and other tests for the diagnosis of respiratory infections, entitled ``Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory Tract Infections.'' The purpose of the public workshop is to provide an opportunity to share information and perspectives with health care providers, academia, and industry on various aspects of diagnostic test development for respiratory infections. Topics for discussion will include the role of emerging diagnostic tests in promoting appropriate use of antibiotics by physicians, the use of novel diagnostic tests in the study of new drugs for respiratory infections, and the possible contribution of biomarkers in the approach to treatment of respiratory infections.