Zdrowie i gospodarka · 27/01/2004

Draft Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions." FDA is revising its March 2002 guidance for industry of the same title to include guidance for sponsors who will be submitting information required by the Best Pharmaceuticals for Children Act (BPCA). The BPCA amended the Public Health Service Act (PHS Act) to require that additional information be included in the Clinical Trials Data Bank established as required by the Food and Drug Administration Modernization Act of 1997 (Modernization Act). This draft guidance explains how to provide that information.