Device Clinical Trials Data Bank: Public Health Need and Impanct on Industry (Includes Appendices). A Report to Congress by the Secretary of Health and Human Services

摘要

Congress enacted the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) on November 21, 1997. Section 113(a) of FDAMA directs the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to set up and manage a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions. To the extent workable, NIH is to integrate the data bank with others containing similar information in the Department of Health and Human Services (DHHS). Section 113(b) of FDAMA directs the Secretary, the Director of NIH, and the Commissioner of Food and Drugs to collaborate and determine the feasibility of listing clinical trials of medical devices in the data bank.