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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The Food and Drug Administration (FDA) is publishing a guidance entitled ‘‘E8 General Considerations for Clinical Trials.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth general scientific principles for the conduct, performance, and control of clinical trials.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1997-D-0440.