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U.S. Department of Health and Human Services

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FDAMA Section 113: Information Program on Clinical Trials for Serious or Life Threatening Diseases: Update on Implementation

Board U-04

J.Derbis, T.Toigo, J.Woods, B.Evelyn, D.Banks, OC, FDA, Rockville MD


Section 113 of the 1997 Food and Drug Modernization Act creates a public resource for information on studies of drug and biological products to treat serious or life-threatening diseases. The NIH, through its National Library of Medicine along with the FDA and others, developed the Clinical Trials Data Bank, known as ClinicalTrials.gov. The FDA guidance, Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions, issued on March 18, 2002. It recommends to industry procedures for submitting protocol information to ClinicalTrials.gov through a Web-based protocol registration system (PRS). FDA is completing a program to educate sponsors about Section 113 and to measure the number of protocols available through ClinicalTrials.gov. Letters were mailed to sponsors of more than 2, 000 INDs in CBER and CDER. The letter informed sponsors about the guidance document and the PRS. Since publication of FDA’s guidance, 731 non-government sponsored clinical trials have been submitted to ClinicalTrials.gov through the PRS.