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ONE IN FOUR PHARMA STATUS REPORTS ON FOLLOW-UP TRIALS ARE LATE OR AREN’T FILED

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By Ed Silverman April 25, 2022

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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.

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ABOUT THE AUTHOR REPRINTS


ED SILVERMAN

Pharmalot Columnist, Senior Writer

Ed covers the pharmaceutical industry.


ed.silverman@statnews.com

@Pharmalot


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