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NME postmarketing safety reviews are labour-intensive, US FDA finds
16 October 2009
Sue Sutter
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...
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16 October 2009
Sue Sutter
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