Zdrowie i gospodarka · 23/08/1995

International Conference on Harmonisation; Draft Guideline on Structure and Content of Clinical Study Reports; Availability

The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Structure and Content of Clinical Study Reports.'' This 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 is intended to facilitate the compilation of a single worldwide core clinical study report acceptable to all regulatory authorities.