Zdrowie i gospodarka · 21/02/2014

FDA Releases Guidance on Electronic Transmission of ICSRs for Improved Data Quality and Analysis

The Food and Drug Administration (FDA) has released a guidance document and an appendix for the electronic transmission of individual case safety reports (ICSRs), aiming to improve data quality and analysis. The guidance was developed under the International Conference on Harmonisation (ICH) and addresses backwards and forwards compatibility with the 2001 ICH E2B guidance.