Zdrowie i gospodarka · 20/10/2011
FDA Publishes Draft Guidance on Electronic Transmission of Individual Case Safety Reports
The FDA has released a draft guidance and appendix on implementing electronic transmission of Individual Case Safety Reports (ICSRs) to improve data quality and analysis, under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Source: Federal Register — Health and Human ServicesOpen original release →