Government Unveils New Proposed Rule for Reporting Results of Clinical Trials

November 19, 2014 5:56 PM

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Government Unveils New Proposed Rule for Reporting Results of Clinical Trials

The US Department of Health and Human Services (DHHS) today unveiled new proposed requirements for its online clinical trials register, ClinicalTrials.gov, that will require pharmaceutical and medical device companies to submit more information regarding patient enrollment, the progress of trials and the results of those trials.

Under section 801 of the Public Health Service Act (PHSA), as amended by the Food and Drug Administration Amendments Act (FDAAA) of 2007, DHHS was directed to establish a clinical trial registry data bank. That data bank, www.ClinicalTrials.gov, is run by the National Institutes of Health (NIH)'s Na...

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