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# Guidance on Safety Data for Late-Stage Trials
- URL: https://www.fdaweb.com/guidance-on-safety-data-for-late-stage-trials/
- Published: 2016-02-19T12:00:00.000Z
- Updated: 2026-09-15T02:37:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134829

*Federal Register* Notice: FDA is making available a guidance for industry entitled *Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations.* It is intended to help sponsors determine the amounts and types of safety data to collect based on what is already known about a drug’s safety profile. FDA believes that selective safety data collection may be possible for some late-stage premarket and postapproval clinical investigations because certain aspects of a drug’s safety profile will be sufficiently well-established and comprehensive data collection is not needed. This guidance finalizes the draft guidance issued 2/2012\. To download this guidance, click [here.](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291158.pdf?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-02-19/pdf/2016-03462.pdf?ref=fdaweb.com)