groups » Global Health News, Events and Conferences » FDA requests comments: Clinical Trials Registration and Results Submission

The FDA is seeking comments on its requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drugs (including biological products) and devices and for pediatric postmarket surveillances of a device to ClinicalTrials.gov.
The proposed requirements would apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drugs (including biological products) and devices that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device that are ordered by FDA. Comments are due on or before February 19, 2015.
Read more at http://www.regulations.gov/#!documentDetail;D=NIH-2011-0003-0003

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