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Zdrowie i gospodarka · 30.05.1997

International Conference on Harmonisation; Draft Guideline on General Considerations for Clinical Trials; Availability

The Food and Drug Administration (FDA) is publishing a draft guideline entitled, ``General Considerations for Clinical Trials.'' The draft guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guideline sets forth general scientific principles for the conduct, performance, and control of clinical trials.

Source: Federal Register — Food and Drug AdministrationOpen original release →