FDA Finalizes Guidance on Safety Data Collection for Late-Stage and Postapproval Trials

Feb 18, 2016, 12:38 by Michael Croft

RAPS | The US Food and Drug Administration (FDA) on Thursday significantly revised and finalized guidance originally released in 2012 that will help industry understand what types of safety data needs to be collected in late-stage premarket and postapproval clinical investigations.

February 18, 2016 | The US Food and Drug Administration (FDA) on Thursday significantly revised and finalized guidance originally released in 2012 that will help industry understand what types of safety data needs to be collected in late-stage premarket and postapproval clinical investigations. RAPS