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US drug regulator issues its first ever non-compliance notice for not posting trial results

BMJ 2021; 373 doi: https://doi.org/10.1136/bmj.n1384 (Published 28 May 2021) Cite this as: BMJ 2021;373:n1384
  1. Janice Hopkins Tanne
  1. New York

The US drug regulator is reviewing a drug company’s reporting of a study on www.clinicaltrials.gov, after it issued its first ever notice of non-compliance last month when the company failed to file the study’s results on time.

The Food and Drug Administration gave Acceleron Pharma, of Cambridge, Massachusetts, 30 days to comply with the notice and warned that failure could mean a fine of $10 000 (£7045; €8200) a day and/or criminal penalties.12

Clinicaltrials.gov was established in 2000 as a public repository of clinical trials sponsored by academic institutions, hospitals, private companies, government research organisations, and individual researchers to make research widely available to doctors and the public and to prevent data about drugs from being hidden. There is a legal requirement for …

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