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FDA creates Guidance on ISS/ISE Placement

Submitted by Leah_Kleylein on Tue, 04/21/2009 - 14:34.
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This morning I saw that FDA put out an actual guidance on placement of the ISS/ISE.

Guidances CDER is Planning for 2009

Submitted by Leah_Kleylein on Tue, 02/10/2009 - 14:00.
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CDER has put out their list for 2009 of planned guidances.  The few that relate directly (or indirectly) to Regulatory Operations are:

Australian eCTD Guidance

Submitted by Leah_Kleylein on Mon, 01/19/2009 - 14:47.
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Australia has put out some updated guidance and draft guidance on eCTD.  There is now a version 2.1 of the AU Module 1 Specification, and a draft version 1.5 of their guidance on submissions in eCTD format.  Both can be found on the TGA's website, the link is below.  Happy reading!

http://www.tga.gov.au/docs/html/eugctd.htm