https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/ISS-and-ISE/m-p/11701#M861 Hello<BR /> <BR /> Please tell me about ISS and ISE<BR /> <BR /> SAS Community member. Fri, 18 Apr 2008 09:34:00 GMT deleted_user 2008-04-18T09:34:00Z https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/ISS-and-ISE/m-p/11701#M861 Hello<BR /> <BR /> Please tell me about ISS and ISE<BR /> <BR /> SAS Community member. Fri, 18 Apr 2008 09:34:00 GMT https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/ISS-and-ISE/m-p/11701#M861 deleted_user 2008-04-18T09:34:00Z https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/ISS-and-ISE/m-p/11702#M862 Hi:<BR /> There are many Google hits on the string:<BR /> ISS ISE<BR /> <BR /> This is from the first hit:<BR /> <A href="http://www.krctraining.com/faq/faq136.htm" target="_blank">http://www.krctraining.com/faq/faq136.htm</A><BR /> <B><BR /> FDA can request to submit Integrated Summary of Safety and Effectiveness (ISS/ISE) usually after starting of marketing.</B><BR /> <BR /> And of course, the FDA was prominent in returned hits from Google:<BR /> <A href="http://www.fda.gov/cder/regulatory/ersr/ISS_ISE_clarification.htm" target="_blank">http://www.fda.gov/cder/regulatory/ersr/ISS_ISE_clarification.htm</A><BR /> <BR /> and others:<BR /> <A href="http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=92010" target="_blank">http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=92010</A><BR /> <BR /> cynthia Fri, 18 Apr 2008 15:27:20 GMT https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/ISS-and-ISE/m-p/11702#M862 Cynthia_sas 2008-04-18T15:27:20Z