Issue Date: February 19, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
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 (see section V of this guidance).
Download the Guidance Document
