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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Report by Clinical Trials Transformation Initiative identifies barriers to registration and reporting of clinical trial results to ClinicalTrials.gov and the need for centralized approach to monitor process and educate those responsible for submitting information to the site.
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.