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# Drug Safety Data Collection Guide
- URL: https://www.fdaweb.com/drug-safety-data-collection-guide/
- Published: 2019-06-27T12:00:00.000Z
- Updated: 2026-09-15T01:35:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144438

*Federal Register* notice: FDA has made available a draft guide entitled “E19 Optimization of Safety Data Collection.” The document provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or post-marketing studies of drugs where the safety profile is well understood and documented. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-06-27/pdf/2019-13702.pdf?ref=fdaweb.com).