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# ICH Clinical Studies Draft Guide Released
- URL: https://www.fdaweb.com/ich-clinical-studies-draft-guide-released/
- Published: 2019-07-31T12:00:00.000Z
- Updated: 2026-09-15T01:41:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144654

FDA has made available a draft guidance entitled “[E8(R1) General Considerations for Clinical Studies](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=FDA%20announces%20availability%20of%20International%20Council%20for%20Harmonisation%20%28ICH%29%20draft%20guidance%20on%20E8%28R1%29&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=9009&elqTrackId=F4E4792AA78137D3C85FC6C204D626CA&elq=9b8cc99b52db4770b5e11742e5d6face&elqaid=8958&elqat=1).” The International Council for Harmonization document describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. In addition, it provides an overview of the types of clinical studies that sponsors may perform and data sources they may use during the product’s life cycle. The guidance also intends to promote the quality of the studies submitted to regulatory authorities, while allowing for flexibility.