Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted

Posted 07 December 2017 By Zachary Brennan

The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies.

The report found that the majority of post-marketing requirements (PMRs) and post-marketing commitments (PMCs) are progressing on schedule, though of those studies that are open (734 NDAs and 156 BLAs are open as of 30 September 2016) and on-schedule, few PMRs for new drug applications (NDAs) and biologic license applications (BLAs) have been submitted to the agency.

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"As of September 30, 2016, most open, on-schedule NDA PMCs were pending (36 percent; 62/174) and most open, on-schedule BLA PMCs were ongoing (43 percent; 83/191)," the report says.

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"The majority of closed PMRs were fulfilled (72 percent of NDA PMRs and 82 percent of BLA PMRs) at the end of FY2016. Similarly, the majority of closed PMCs were fulfilled at the end of FY2016," the report adds.

The report also shows the progression on the summary of status of postmarketing requirements from 2010 to 2016.

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Federal Register

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Categories: Biologics and biotechnology, Drugs, Government affairs, Research and development, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: post-approval studies, research requirements, post-marketing research

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