More US FDA Enforcement Of Clinical Trial Reporting Is Expected After Acceleron’s ‘Clerical Oversight’
‘Vast majority’ of 40 parties who received pre-notices of non-compliance with reporting requirements took action, FDA says. First noncompliance letter to Acceleron has prompted speedy response from sponsors.
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Potential fallout from noncompliance goes well beyond regulatory penalties; adherence has improved but less so for smaller companies.
Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved drugs will become available under ruling against HHS; co-plaintiff sought eteplirsen study data.
ClinicalTrials.gov Still Lacks Many Study Results, JAMA Finds; Do Transparency Efforts Need A Boost?
Industry data transparency initiatives are well-established now, but JAMA study suggests holes in efforts to publicly release clinical trial results.