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NIH to Hear Public on Adverse Events Data

NEW YORK (GenomeWeb News) – The National Institutes of Health will hold a public meeting this month to hear from parties who are interested in discussing expansion of the information held in the government's clinical trials registry and related data bank.

The Food and Drug Administration Amendments Act of 2007 mandated the establishment of a results data bank, which was launched in September of 2008, and the inclusion of information about adverse events from clinical trials. The law also requires the creation of rules and draft regulations about how to expand the clinical trial registry and data bank, and these will be developed with help from public comments from the meeting.

The meeting in Bethesda, Md., is scheduled for Apr. 20.

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