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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Yale researchers call on FDA to send more pre-notices of noncompliance to those who have not reported trial results. Of 58 pre-notices in last eight years, 56% went to pharma industry and none went to federal agencies. Commissioner-in-waiting Califf is expected to focus on trial reporting.
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.