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Afederal judge in the Southern District of New York has ruled that sponsors of clinical trials conducted between 2007 and 2017 are failing to comply with federal law if they do not post their studies’ results to ClinicalTrials.gov, according to STAT. The decision stipulates that reporting requirements outlined in a 2017 final rule to the Food and Drug Administration Amendments Act are applicable to trials completed as far back as 2007, and not just those finished after 2017 as government agencies had mistakenly interpreted the law, reports Endpoints News.
“This decision brings us one step closer to what federal law requires—providing the American public with complete access to clinical trial results on drugs and medical devices approved by the FDA,” the plaintiff’s supervising attorney Christopher Morten tells STAT, adding that the ruling “makes it harder for drug companies, device manufacturers, and other trial sponsors to ...
