Drug companies failed to submit 11% of status reports for clinical trials they were required or had agreed to conduct when their medicines were initially approved, according to a new analysis that tracked more than 700 reports during the 12-month period ending September 2020. Another 13% of those follow-up trials were submitted late.
Meanwhile, a quarter of nearly 1,600 of these so-called post-marketing requirements and commitments were not progressing on schedule, which means the follow-up trials were either delayed or ended. And three dozen trials that were required as a condition for receiving accelerated approval were also delayed or ended, the U.S. Food and Drug Administration report found.
The findings were issued in the latest annual report from the FDA, which examines the status of clinical trials that companies run after receiving approval for a medicine. The data are generally viewed as a barometer of industry cooperation with the agency in exchange for regulatory flexibility in granting approvals.
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