Did you know the ISO adverse drug reaction reporting format will be mandatory by June 2022

The European Medicines Agency’s (EMA) management board has agreed to make the International Organisation for Standardisation’s (ISO) individual case safety report (ICSR) format mandatory for suspected adverse drug reaction (ADR) reporting to EudraVigilance. Read more “Did you know the ISO adverse drug reaction reporting format will be mandatory by June 2022”

The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications

The United States (US) Food and Drug Administration (FDA) is taking steps towards making electronic submission of safety reports for investigational new drug applications (INDs) into their Adverse Event Reporting System (FAERS), a requirement. Read more “The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications”