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NME postmarketing safety reviews are labour-intensive, US FDA finds

This article was originally published in Scrip

Executive Summary

A US FDA pilot programme that reviewed the postmarketing safety of five new molecular entities (NMEs) identified a total of 22 safety issues for follow-up, consumed more than 1,000 staff hours and showed no strong correlation between the time needed to conduct the analyses and the extent of a drug's use or number of adverse event reports.

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