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FDA-NEWSDIGEST

Sent: Friday, February 03, 2006 11:39 AM
To: 'FDAGCPP@LIST.NIH.GOV'
Subject: February 2006 Updates

Today, FDA announced its Information Sheet Guidance Initiative to update its process for developing, issuing and making available guidances intended for institutional review boards (IRBs), clinical investigators, and sponsors.  Know as "Information Sheets", the Information Sheet Guidance Initiative is intended to provide updated information and to issue the Information Sheets in accordance with FDA's good guidance practice.  For more information about this initiative and about the recently revised Information Sheet guidances, please visit FDA's docket management site at:  http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2006&mn=2&dy=3

The recently revised Information Sheet guidances are now available on the Good Clinical Practice Program's home page.  You can learn more about the information sheet guidance initiative and the newly revised information sheet guidances by visiting www.fda.gov/oc/gcp and clicking the first item under the "In the News" section. 

Shortly, information about this initiative and electronic postings of the revised guidances will be available directly from the Good Clinical Practice Program's (GCPP) web site.   In a separate e-mail notice, you will receive details about postings of these new Information Sheet Guidances to the GCPP web page.