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Zdrowie i gospodarka · 09/07/2001

Draft Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Implementation Plan; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Implementation Plan." The draft guidance discusses procedures for submission of protocol information to the Clinical Trials Data Bank established under section 113 of the Food and Drug Administration Modernization Act (Modernization Act), which required the establishment of this data bank and specified what information was to be submitted for it. Procedural issues discussed in this guidance document were not included in an earlier draft guidance document on the scope of the Data Bank, which published in the Federal Register on March 29, 2000 (65 FR 16620).

Source: Federal Register — Food and Drug AdministrationOpen original release →