FDA Draft Guidance on Safety Data Collection for Late Stage Premarket & Postmarket Investigations

This post was written by Erin Janssen and Celeste Letourneau.

The FDA has released draft guidance for industry entitled “Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations.” This draft guidance is intended to assist sponsors of certain late stage premarket and postmarket investigations in developing selective/targeted safety data collection for ongoing product characterization. Consistent with FDA’s evolving “quality over quantity” approach to safety assessment, this guidance provides recommendations on the type and amount of safety information that may be acceptable based on what is already known about a drug’s safety profile when certain aspects of a drug’s safety profile are sufficiently well established that comprehensive data collection is not needed. FDA’s view is that more selective or targeted safety data collection in appropriate circumstances may improve the quality of the safety assessment without compromising the integrity of the trial results. Selective/targeted collection may also serve lower costs and ease the burdens associated with conducting studies, which may ultimately result in improved use of clinical trial resources while providing long-term safety information. Comments on the guidance may be submitted until April 10, 2012.


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