Zdrowie i gospodarka · 29/03/2000
Draft Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank." The draft guidance provides recommendations for sponsors of investigational new drug applications (IND's) on submitting information about clinical trials for serious or life-threatening diseases to a clinical trials data bank developed by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Section 113 of the Food and Drug Administration Modernization Act (Modernization Act) required the establishment of this data bank and specified what information was to be submitted for it.