GUIDANCE DOCUMENT
E8 General Considerations for Clinical Trials December 1997
- Docket Number:
- FDA-1997-D-0440
- Issued by:
-
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.
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All written comments should be identified with this document's docket number: FDA-1997-D-0440.