News

FDA given new powers over data reporting to national clinical trials registry

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e6629 (Published 02 October 2012) Cite this as: BMJ 2012;345:e6629
  1. Bob Roehr
  1. 1Washington, DC

The US Food and Drug Administration (FDA) has been given the authority to monitor and enforce the reporting of required data to the national clinical trials registry (ClinicalTrials.gov).

Authority for the registry previously rested with the Secretary of Health but was transferred to the FDA on 26 September.1 The move is seen as a streamlining or rationalization of administrative responsibilities and will probably result in enhanced accountability.

The National Institute for Health’s (NIH) National Library of Medicine operates the ClinicalTrials.gov database. A 2007 change in the law required that “basic results” for certain clinical trials, including those submitted to the FDA for …

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