In a first, FDA warns a researcher for failing to submit data 3 years after trial completion
For the first time ever, the FDA has threatened an individual clinical trial investigator with a fine after he failed to publish trial data on a government database. The warning is part of a wider attempt to hold researchers and companies accountable for submitting trial results after trials finish.
Andrey Petrikovets, a surgeon from Los Angeles, ran a study on pain drug regimens following vaginal pelvic floor reconstructive surgery, but failed to publish results on time, the FDA said in a warning letter posted this week.
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