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US FDA Posts Report on Postmarketing Surveillance
The US Food and Drug Administration (FDA) has posted a report on the performance of pharmaceutical companies in performing postmarketing surveillance in 2018, entitled Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments Fiscal Year 2018.
“Our most recent report shows that in fiscal year 2018, the majority of these studies were successfully completed or are progressing toward completion according to the original schedule, with very few studies delayed,” said Dr. Ned Sharpless, Acting FDA Commissioner. “A delay doesn’t necessarily mean a study isn’t taking place—the study may be ongoing, but behind the original timeline because it was more difficult than anticipated to enroll participants in the clinical trial, or a complex study protocol required extended discussions between the applicant and the FDA. Additionally, emerging scientific information may result in a need to complete...