Zdrowie i gospodarka · 07/03/1996

International Conference on Harmonisation; Draft Guideline for the Photostability Testing of New Drug Substances and Products; Availability

The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Guideline for the Photostability Testing of New Drug Substances and Products.'' 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 describes the basic testing protocol for photostability testing of new drug substances and products in original new drug application (NDA) submissions. The draft guideline is an annex to the ICH guideline entitled ``Stability Testing of New Drug Substances and Products.''