Clinical Trial Disclosure: Only ‘Tiny Fraction’ Of Thousands Of Unreported Results Cited By US FDA
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.
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President Biden’s pick for FDA commissioner should remember many of the hot-button issues that he would face upon confirmation, such as drug pricing and approval standards.
Many supporters believe Robert Califf checks all the boxes, but if nominated he would also face many familiar confirmation challenges.
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.