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

摘要

The Food and Drug Administration (FDA) is publishing a guideline entitled ``Guideline for the Photostability Testing of New Drug Substances and Products.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline describes the basic testing protocol for photostability testing of new drug substances and products in original new drug application submissions. The guideline is an annex to the ICH guideline entitled ``Stability Testing of New Drug Substances and Products.'' DATES: Effective May 16, 1997. Submit written comments at any time.