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# Draft Guide on Drug Study General Considerations
- URL: https://www.fdaweb.com/draft-guide-on-drug-study-general-considerations/
- Published: 2019-08-01T12:00:00.000Z
- Updated: 2026-09-15T01:41:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144671

*Federal Register* notice: FDA has made available a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for designing and conducting drug/biologic clinical studies. In addition, it addresses the types of clinical studies that may be performed and data sources during a product’s life cycle. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-08-01/pdf/2019-16384.pdf?ref=fdaweb.com).