Regulacje i polityka gospodarcza · 1.10.1996

International Conference on Harmonisation; Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports

The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Data Elements for Transmission of Individual Case Safety Reports.'' 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 standardize the data elements for the electronic transmission of individual case safety reports for both preapproval and postapproval reporting periods.