[RegAffairs]DMF Annual Reports

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[RegAffairs]DMF Annual Reports

To: "RegAffairs" <RegAffairs@www2.pharmweb.net>
Subject: [RegAffairs]DMF Annual Reports
From: "Globepharm /Consulting" <consulting@globepharm.org>
Date: Mon, 18 Jan 2010 22:31:38 +0000
Delivery-date: Mon, 18 Jan 2010 22:38:00 +0000
Envelope-to: hm0090@www.pharmweb.net
Operating-System: PharmWeb - http://www.pharmweb.net
Reply-To: "RegAffairs" <RegAffairs@www2.pharmweb.net>
Sender: <RegAffairs@www2.pharmweb.net>

Dear Colleagues:

When submitting an annual update to a DMF, should this be titled 
"Amendment (say 5) to the DMF", or will this confuse FDA.

What is the best way to title a "DMF Annual Update"

With Best Regards,

Michael Anisfeld
Globepharm
e-mail: consulting@globepharm.org

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