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Posted 04-18-2008 05:34 AM
(4013 views)
Hello
Please tell me about ISS and ISE
SAS Community member.
Please tell me about ISS and ISE
SAS Community member.
1 REPLY 1
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Hi:
There are many Google hits on the string:
ISS ISE
This is from the first hit:
http://www.krctraining.com/faq/faq136.htm
FDA can request to submit Integrated Summary of Safety and Effectiveness (ISS/ISE) usually after starting of marketing.
And of course, the FDA was prominent in returned hits from Google:
http://www.fda.gov/cder/regulatory/ersr/ISS_ISE_clarification.htm
and others:
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id...
cynthia
There are many Google hits on the string:
ISS ISE
This is from the first hit:
http://www.krctraining.com/faq/faq136.htm
FDA can request to submit Integrated Summary of Safety and Effectiveness (ISS/ISE) usually after starting of marketing.
And of course, the FDA was prominent in returned hits from Google:
http://www.fda.gov/cder/regulatory/ersr/ISS_ISE_clarification.htm
and others:
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id...
cynthia