Zdrowie i gospodarka · 05/04/1996

International Conference on Harmonisation; Draft Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; Availability

The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Clinical Safety Data Management: Periodic Safety Update Reports For Marketed Drugs.'' 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 provides a unified standard for the format, content, and reporting frequency for postmarketing periodic safety update reports. The draft guideline also provides definitions and terms for key aspects of postmarketing periodic safety reporting. The guideline is intended to help harmonize collection and submission of postmarketing clinical safety data.