NME postmarketing safety reviews are labour-intensive, US FDA finds
This article was originally published in SRA
A US Food and Drug Administration pilot programme that reviewed the postmarketing safety of five new molecular entities identified a total of 22 safety issues for follow-up1. The project took more than 1,000 staff hours but the results 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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