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News From the Food and Drug Administration
May 1, 2002

Data Bank Submissions

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JAMA. 2002;287(17):2203. doi:10.1001/jama.287.17.2203-JFD20005-3-1

The FDA has issued a guidance to assist sponsors who will be submitting information to the Clinical Trials Data Bank established under the Food and Drug Administration Modernization Act of 1997 (FDAMA). The data bank is intended to be a central comprehensive resource, providing current information on certain clinical trials to patients, other members of the public, and health care providers and researchers.

The FDAMA requires that sponsors of all federally and privately funded clinical trials for experimental drugs and biological products that are conducted under an investigational new drug (IND) application post data to the databank, provided that the studies are for treatment of a serious or life-threatening disease or condition and that trials are designed to test effectiveness. If they wish, sponsors can also provide information on other trials conducted under an IND application.