Zdrowie i gospodarka · 17/12/1997
International Conference on Harmonisation; Guidance on General Considerations for Clinical Trials
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.