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FAQ: ClinicalTrials.gov - What is the FDAMA?


Question: What is the Food and Drug Administration Modernization Act (FDAMA)?
Answer:

The Food and Drug Administration Modernization Act (FDAMA) was passed by the U.S. Congress in 1997 and contains a number of sections related to the regulation of food, drugs, devices, and biological products.

In particular, Section 113 - Information Program on Clinical Trials for Serious and Life-Threatening Diseases, "requires the U.S. Department of Health and Human Services, through the National Institutes of Health, to establish a registry of clinical trials for both federally and privately funded trials of experimental treatments for serious or life-threatening diseases."


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http://www.nlm.nih.gov/services/ctfdama.html