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- W4367159383 abstract "In an unprecedented action, the US Food and Drug Administration is threatening to fine a clinical trial sponsor for failing to publish study results on ClinicalTrials.gov . Federal law requires clinical trial investigators to register their studies on the website within 21 days of enrolling the first participant. Sponsors must also submit a summary of the trial results within 1 year of the study’s completion date. In a statement issued April 28 , the FDA says Acceleron Pharma hasn’t complied. The company ended a trial for dalantercept in combination with axitinib in patients with advanced renal cell carcinoma in 2017, making its results 3 years overdue. Last year, the agency sent Acceleron a letter warning that it could be fined . The company now has 30 days to comply or will be fined up to $12,316 for each day the violation is not corrected, an FDA spokesperson says. ClinicalTrials.gov was" @default.
- W4367159383 created "2023-04-28" @default.
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- W4367159383 date "2021-05-10" @default.
- W4367159383 modified "2023-09-28" @default.
- W4367159383 title "FDA threatens to fine first drug firm for failing to post results to ClinicalTrials.gov" @default.
- W4367159383 doi "https://doi.org/10.1021/cen-09917-polcon4" @default.
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