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GUIDANCE DOCUMENT

E8 General Considerations for Clinical Trials December 1997

Final
Docket Number:
FDA-1997-D-0440
Issued by:
Guidance Issuing Office
Center 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.
 


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