ISS and ISE

[deleted_user]

Hello

Please tell me about ISS and ISE

SAS Community member.

[Cynthia_sas]

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