Zdrowie i gospodarka · 04/04/1997

International Conference on Harmonisation; Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceuticals; Availability

The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceuticals.'' 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 is intended to provide general principles for the design of internationally acceptable preclinical safety evaluation programs for biopharmaceuticals.