Zdrowie i gospodarka · 19/05/1997

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

The Food and Drug Administration (FDA) is publishing a guideline entitled ``Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs.'' 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 recommends a unified standard for the format, content, and reporting frequency for postmarketing periodic safety update reports for drugs and biological products. The 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.