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# Final Guide on ICH Drug Study Considerations
- URL: https://www.fdaweb.com/final-guide-on-ich-drug-study-considerations/
- Published: 2022-04-08T12:00:00.000Z
- Updated: 2026-09-14T17:39:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151551

*Federal Register* notice: FDA is making available a final guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for the design and conduct of drug/biologic clinical studies. It also provides an overview of the types of clinical studies that may be performed and data sources used during the product’s lifecycle. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-07690.pdf?ref=fdaweb.com).