FDA issues new Guidance on Safety Data in late Stage Trials

Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations

This guidance is intended to help sponsors determine the amount and types of safety data to collect during late-stage premarket and postapproval clinical investigations, (e.g., phase 3 clinical trials, studies of new uses, long-term outcomes). This guidance discusses a selective approach to safety data collection during late-stage premarket development or during the postapproval stage based on what is already known about a drug’s safety profile. This guidance provides recommendations on when to consider selective safety data collection and how to do so to maintain a balance between eliminating the collection of data that will not be useful and collecting sufficient data to allow adequate characterization of the safety profile of a drug. In addition, this guidance provides information to sponsors about consulting with the relevant FDA review division or divisions to determine whether a selective approach to safety data collection would be appropriate.

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