The Crucial Role of Medical Writers in Successful ISS and ISE Submissions
After the United States Food and Drug Administration (US FDA)’s guidance document, titled ‘Integrated Summaries of Safety and Effectiveness (ISS/ISE): Location Within the Common Technical Document,’ was released in April 2009, the significance of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) increased. ISS and ISE are pre-approval Regulatory submission documents for new drugs and biologics.